The following data is part of a premarket notification filed by Air Safety Ltd with the FDA for Model 2800 Pft Filter.
| Device ID | K051712 |
| 510k Number | K051712 |
| Device Name: | MODEL 2800 PFT FILTER |
| Classification | Spirometer, Diagnostic |
| Applicant | AIR SAFETY LTD 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden AIR SAFETY LTD 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-27 |
| Decision Date | 2005-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 35060120951671 | K051712 | 000 |