Data / Medical devices / United Kingdom / KoKo PFT LTD.
KoKo PFT LTD.: FDA-registered device maker in Waltham Abbey Essex, United Kingdom, 6 510(k) clearances
KoKo PFT LTD. is registered with the FDA (registration 3006254047) in Waltham Abbey Essex, United Kingdom. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated September 21, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006254047
- Address
- 112D Brooker Road, Waltham Abbey Essex, United Kingdom, EN9 1JH
- Owner or operator
- KoKo PFT LTD (9100499)
- Roles
- Manufacturer
- First device listed
- April 18, 2008
- Registered through
- 2026
- Brand names listed
- CALCULATOR, PULMONARY FUNCTION DATASPIROMETER, DIAGNOSTIC, Filter, bacterial, breathing-circuit, Koko PFT Ltd 112D Brooker Road, Waltham Abbey, Essex EN9 1JH, United Kingdom., SPIROMETER, DIAGNOSTIC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Pulmonary Function Data | BZC | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Manufacturer | accessdata.fda.gov |
| Spirometer, Monitoring (W/Wo Alarm) | BZK | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| September 21, 2009 | K091853 | WRIGHT RESPIROMETER, MARK 8, AND 14 RESPIROMETER, MODEL 700-021, 700-008, 700-014 | BZK | Substantially Equivalent | Nspire Health, Inc. | accessdata.fda.gov |
| January 12, 2006 | K052176 | FLOWHANDY ZAN100 USB | BZG | Substantially Equivalent | Zan Messgerate GmbH | accessdata.fda.gov |
| December 22, 2005 | K052328 | ZAN LUNG-FUNCTION LAB | BZC | Substantially Equivalent | Zan Messgerate GmbH | accessdata.fda.gov |
| May 14, 2003 | K030917 | GEM; HAWK; EAGLE; MODELS 004110, 0044120, 004130 | BZG | Substantially Equivalent | Collins Medical, Inc. | accessdata.fda.gov |
| October 21, 1993 | K934475 | KOKO FILTER II | CAH | Substantially Equivalent | Pulmonary Data Services Inst., Inc. | accessdata.fda.gov |
| July 2, 1992 | K914272 | KOKO SPIROMETER | BZG | Substantially Equivalent | Ferraris Respiratory, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Spirometer, Diagnostic
- All makers of Spirometer, Monitoring (W/Wo Alarm)
- All makers of Calculator, Pulmonary Function Data
Updated September 21, 2009. 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.