The following data is part of a premarket notification filed by Spirometrics, Inc. with the FDA for Peak Flow Monitor.
| Device ID | K915059 |
| 510k Number | K915059 |
| Device Name: | PEAK FLOW MONITOR |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | SPIROMETRICS, INC. 33 OMNI CIRCLE Auburn, ME 04210 -1210 |
| Contact | Ann M.therriault |
| Correspondent | Ann M.therriault SPIROMETRICS, INC. 33 OMNI CIRCLE Auburn, ME 04210 -1210 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-08 |
| Decision Date | 1992-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00855784004245 | K915059 | 000 |
| 00855784004054 | K915059 | 000 |
| 00855784004030 | K915059 | 000 |