The following data is part of a premarket notification filed by Ias with the FDA for Ias Anesthesia Mask.
| Device ID | K915558 |
| 510k Number | K915558 |
| Device Name: | IAS ANESTHESIA MASK |
| Classification | Mask, Gas, Anesthetic |
| Applicant | IAS 386 BROADWAY Newburgh, NY 12550 |
| Contact | Daniel J Slheehan |
| Correspondent | Daniel J Slheehan IAS 386 BROADWAY Newburgh, NY 12550 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-11 |
| Decision Date | 1992-04-08 |