The following data is part of a premarket notification filed by Monaghan Medical Corp. with the FDA for Strive Dual Zone Peak Flow Meter.
| Device ID | K123945 |
| 510k Number | K123945 |
| Device Name: | STRIVE DUAL ZONE PEAK FLOW METER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | MONAGHAN MEDICAL CORP. 5 LATOUR AVE., SUITE 1600 Plattsburgh, NY 12901 |
| Contact | Cari J Reil |
| Correspondent | Cari J Reil MONAGHAN MEDICAL CORP. 5 LATOUR AVE., SUITE 1600 Plattsburgh, NY 12901 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-21 |
| Decision Date | 2013-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00604351966109 | K123945 | 000 |