The following data is part of a premarket notification filed by Dynamitech Medical, Inc with the FDA for Dynamipeak Peak Flow Meter.
| Device ID | K082899 |
| 510k Number | K082899 |
| Device Name: | DYNAMIPEAK PEAK FLOW METER |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | DYNAMITECH MEDICAL, INC PACIFIC NORTHWEST BRANCK 611 S. SCHOOLHOUSE CREEK RD Grants Pass, OR 97526 |
| Contact | Keith Lowrey |
| Correspondent | Keith Lowrey DYNAMITECH MEDICAL, INC PACIFIC NORTHWEST BRANCK 611 S. SCHOOLHOUSE CREEK RD Grants Pass, OR 97526 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-30 |
| Decision Date | 2009-03-10 |
| Summary: | summary |