K942170 is an FDA 510(k) clearance for the MODEL 511 INFANT MONITOR. This device is classified as a Monitor, Breathing Frequency (Class II - Special Controls, product code BZQ).
Submitted by Ge Medical Systems Information Technologies (Wallingford, US). The FDA issued a Cleared decision on June 2, 1995, 394 days after receiving the submission on May 4, 1994.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2375.
| 510(k) Number | K942170 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Third Party Review (ST) |
| Date Received | May 04, 1994 |
| Decision Date | June 02, 1995 |
| Days to Decision | 394 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | - |
| Product Code | BZQ - Monitor, Breathing Frequency |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2375 |