Data / Medical devices / United States / Futuremed America, Inc.
Futuremed America, Inc.: FDA-registered device maker in Granada Hills, CA, United States, 9 510(k) clearances
Futuremed America, Inc. is registered with the FDA (registration 2433214) in Granada Hills, CA, United States. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated March 10, 2004. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2433214
- Address
- 15700 Devonshire St, Granada Hills, CA, United States, 91344
- Owner or operator
- FUTUREMED AMERICA, INC. (2433214)
- Roles
- Repackager or relabeler
- First device listed
- December 29, 2008
- Registered through
- 2026
- Brand names listed
- Discovery Spirometer, Discovery-2, Discovery-2 Spirometer, Futuremed SpiroVision-3+ PC Based Spirometer, Futuremed Spirometry Filters, P80 ECG, P8000-Power, ST-90 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator, Predicted Values, Pulmonary Function | BTY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Calculator, Pulmonary Function Data | BZC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrocardiograph | DPS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Repackager or relabeler | accessdata.fda.gov |
| LOS | LOS | Repackager or relabeler | accessdata.fda.gov | |
| Mouthpiece, Breathing | BYP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Spirometer, Diagnostic | BZG | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 10, 2004 | K033518 | LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 | BZG | Substantially Equivalent | Custom Plastic Products | accessdata.fda.gov |
| January 2, 2003 | K020745 | COSMED MICROQUARK | BTY | Substantially Equivalent | Cosmed Srl | accessdata.fda.gov |
| November 14, 2000 | K000654 | VBMAX | CAH | Substantially Equivalent | A-M Systems, Inc. | accessdata.fda.gov |
| June 25, 1996 | K953948 | SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO | BZG | Substantially Equivalent | Futuremed America, Inc. | accessdata.fda.gov |
| December 19, 1995 | K953396 | CARDIOVIT AT-1C, AT-2C | LOS | Substantially Equivalent | Schiller America, Inc. | accessdata.fda.gov |
| November 17, 1995 | K950223 | DISCOVERY GRAPHIC PORTABLE SPIROMETER | BZG | Substantially Equivalent | Futuremed America, Inc. | accessdata.fda.gov |
| March 16, 1995 | K946205 | CARDIOVIT AT-1, P-80 | DPS | Substantially Equivalent | Schiller America, Inc. | accessdata.fda.gov |
| February 10, 1994 | K933511 | UPGRADED SPIROMETER ST-90 | BTY | Substantially Equivalent | Futuremed Div. of Future Impex Corp. | accessdata.fda.gov |
| July 23, 1990 | K901308 | SPIRO ANALYZER MODEL ST 250 | BZG | Substantially Equivalent | Futuremed Div. of Future Impex Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of LOS
- All makers of Mouthpiece, Breathing
- All makers of Electrocardiograph
- All makers of Calculator, Predicted Values, Pulmonary Function
- All makers of Calculator, Pulmonary Function Data
- All makers of Spirometer, Diagnostic
Updated March 10, 2004. 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.