K801254 is an FDA 510(k) clearance for the PENLON I.D.P. PRESSSURE FAILURE ALARM. This device is classified as a Monitor, Airway Pressure (includes Gauge And/or Alarm) (Class II - Special Controls, product code CAP).
Submitted by Penlon, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980, 12 days after receiving the submission on May 28, 1980.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2600.
| 510(k) Number | K801254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1980 |
| Decision Date | June 09, 1980 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAP — Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2600 |