K822356 is an FDA 510(k) clearance for the MODULAIDE EMERG. CARDIAC LIFE SUPP. KT. This device is classified as a Ventilator, Emergency, Manual (resuscitator) (Class II - Special Controls, product code BTM).
Submitted by Laerdal Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1982, 14 days after receiving the submission on August 6, 1982.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5915.
| 510(k) Number | K822356 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1982 |
| Decision Date | August 20, 1982 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BTM — Ventilator, Emergency, Manual (resuscitator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5915 |