The following data is part of a premarket notification filed by Gomi Medical Instruments with the FDA for Single Breath Lung Diffus Test Device Spirometery.
| Device ID | K874902 |
| 510k Number | K874902 |
| Device Name: | SINGLE BREATH LUNG DIFFUS TEST DEVICE SPIROMETERY |
| Classification | Calculator, Pulmonary Function Interpretor (diagnostic) |
| Applicant | GOMI MEDICAL INSTRUMENTS 740 FAWN DR. San Anselmo, CA 94960 |
| Contact | Gomidas Jibelian |
| Correspondent | Gomidas Jibelian GOMI MEDICAL INSTRUMENTS 740 FAWN DR. San Anselmo, CA 94960 |
| Product Code | BZM |
| CFR Regulation Number | 868.1900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-01 |
| Decision Date | 1988-06-07 |