The following data is part of a premarket notification filed by Air Safety Ltd with the FDA for Air Safety Hepa, Model 3500.
| Device ID | K040712 |
| 510k Number | K040712 |
| Device Name: | AIR SAFETY HEPA, MODEL 3500 |
| Classification | Accessory To Continuous Ventilator (respirator) |
| 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 | MOD |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-18 |
| Decision Date | 2004-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00709078001567 | K040712 | 000 |
| 35060120952555 | K040712 | 000 |
| 25060120952541 | K040712 | 000 |
| 25060120952534 | K040712 | 000 |