Data / Medical devices / India / Philips Global Business Services LLP
Philips Global Business Services LLP: FDA-registered device maker in Baner Pune Maharashtra, India, 15 510(k) clearances
Philips Global Business Services LLP is registered with the FDA (registration 3029227324) in Baner Pune Maharashtra, India. It lists 10 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 10, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3029227324
- Address
- 5th Floor, Amar Madhuban Tech Park, Baner Pune Maharashtra, India, 411045
- Owner or operator
- Philips Medical Systems International BV (2518422)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 9, 2004
- Registered through
- 2026
- Brand names listed
- 12/24V Battery Cable w/terminals or adapter, A30 Heated Humidifier, A40 Heated Humidifier, BiPAP A30 Ventilatory Support System, BiPAP A40 Ventilatory Support System, BiPAP V30 Auto, BiPAP autoSV Advanced, Cough Assist T70 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 10, 2020 | K200480 | DreamStation 2 System, DreamStation 2 Advanced System | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 18, 2019 | K181170 | Trilogy Evo Universal | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| July 18, 2019 | K181166 | Trilogy Evo | CBK | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 18, 2013 | K131982 | REMSTAR AUTO A-FLEX HT | BZD | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 14, 2012 | K121955 | COUGHASSIST T70 DEVICE | NHJ | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| December 14, 2012 | K121623 | BIPAP A 40 VENTILATORY SUPPORT SYSTEM | MNT | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 1, 2012 | K113053 | BIPAP A 30 VENTILATORY SUPPORT SYSTEM | MNS | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| November 4, 2011 | K111885 | SIMPLYGO PORTABLE OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| August 9, 2011 | K110293 | OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER | NVP | Substantially Equivalent | Respironics New Jersey, Inc. | accessdata.fda.gov |
| April 5, 2011 | K102985 | V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS | MNT | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| October 30, 2009 | K090539 | BIPAP AUTOSV ADVANCED | MNS | Substantially Equivalent | Respironics Inc., Sleep & Home Respiratory Group | accessdata.fda.gov |
| January 9, 2009 | K082660 | V60 VENTILATOR, MODEL V8000 | MNT | Substantially Equivalent | Respironics California, Inc. | accessdata.fda.gov |
| June 28, 2006 | K061261 | L4 OXYGEN CONCENTRATOR | CAW | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| February 11, 2005 | K043006 | MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600; WITH OPI, MODEL M10605 | CAW | Substantially Equivalent | Respironics, Inc. | accessdata.fda.gov |
| November 13, 2003 | K032809 | HOSPITAL SPACER | CAF | Substantially Equivalent | Respironics Healthscan, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Oxygen, Portable
- All makers of Continuous, Minimal Ventilatory Support, Facility Use Ventilator
- All makers of Device, Positive Pressure Breathing, Intermittent
- All makers of Holding Chambers, Direct Patient Interface
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
Updated July 10, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.