The following data is part of a premarket notification filed by Center Laboratories, Inc. with the FDA for Astech Peak Flow Meter.
| Device ID | K954277 |
| 510k Number | K954277 |
| Device Name: | ASTECH PEAK FLOW METER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | CENTER LABORATORIES, INC. 35 CHANNEL DR. Port Washington, NY 11050 |
| Contact | Richard J Manassa |
| Correspondent | Richard J Manassa CENTER LABORATORIES, INC. 35 CHANNEL DR. Port Washington, NY 11050 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-11 |
| Decision Date | 1996-02-21 |