The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Airlife Volume Venti. Circuit W/clear Cap Ex Valve.
| Device ID | K873359 |
| 510k Number | K873359 |
| Device Name: | AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE |
| Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Contact | Lawrence W Getlin |
| Correspondent | Lawrence W Getlin AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Product Code | CAI |
| CFR Regulation Number | 868.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-21 |
| Decision Date | 1987-11-06 |