The following data is part of a premarket notification filed by Intl. Medical, Inc. with the FDA for Peak Flow Meter.
| Device ID | K970507 |
| 510k Number | K970507 |
| Device Name: | PEAK FLOW METER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | INTL. MEDICAL, INC. 14470 BURNSVILLE PKWY. Burnsville, MN 55306 |
| Contact | Warren V Bigelow |
| Correspondent | Warren V Bigelow INTL. MEDICAL, INC. 14470 BURNSVILLE PKWY. Burnsville, MN 55306 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-06-13 |