The following data is part of a premarket notification filed by Solcoor, Inc. with the FDA for Peak Flowmeters For Spirometry.
| Device ID | K851265 |
| 510k Number | K851265 |
| Device Name: | PEAK FLOWMETERS FOR SPIROMETRY |
| Classification | Meter, Peak Flow, Spirometry |
| Applicant | SOLCOOR, INC. 1655 N. FT. MYER DR. STE. 700 Arlington, VA 22209 |
| Contact | Barbara A Marsden |
| Correspondent | Barbara A Marsden SOLCOOR, INC. 1655 N. FT. MYER DR. STE. 700 Arlington, VA 22209 |
| Product Code | BZH |
| CFR Regulation Number | 868.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-29 |
| Decision Date | 1985-10-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0050017420 | K851265 | 000 |
| B005001740 | K851265 | 000 |
| B005001730 | K851265 | 000 |