The following data is part of a premarket notification filed by Safey Medical Devices Pvt Ltd with the FDA for Safey Pocket Spirometer.
| Device ID | K201002 |
| 510k Number | K201002 |
| Device Name: | Safey Pocket Spirometer |
| Classification | Spirometer, Diagnostic |
| Applicant | Safey Medical Devices Pvt Ltd 3rd Floor, Office 303, Nyati Emporius, S No 105 H No 4A, Baner Pune, IN 411045 |
| Contact | Taher Ali Moiyed |
| Correspondent | Taher Ali Moiyed Safey Medical Devices Pvt Ltd 3rd Floor, Office 303, Nyati Emporius, S No 105 H No 4A, Baner Pune, IN 411045 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-16 |
| Decision Date | 2020-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08908014292003 | K201002 | 000 |