The following data is part of a premarket notification filed by Narco Scientific with the FDA for Air Shields As-100 Monioring Sys-as105.
| Device ID | K831430 |
| 510k Number | K831430 |
| Device Name: | AIR SHIELDS AS-100 MONIORING SYS-AS105 |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | NARCO SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-03 |
| Decision Date | 1983-09-12 |