The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Airlife Arterial Blood Gas Sampling Syringe.
| Device ID | K870720 |
| 510k Number | K870720 |
| Device Name: | AIRLIFE ARTERIAL BLOOD GAS SAMPLING SYRINGE |
| Classification | Arterial Blood Sampling Kit |
| Applicant | AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Contact | Robert T Merrick |
| Correspondent | Robert T Merrick AMERICAN PHARMASEAL DIV. AHSC 27200 NORTH TOURNEY RD. POST OFFICE BOX 5900 Valencia, CA 91355 |
| Product Code | CBT |
| CFR Regulation Number | 868.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-20 |
| Decision Date | 1987-03-17 |