K771684 is an FDA 510(k) clearance for the AMPLIFIER MODEL N5A-ECG. This device is classified as a System, Signal Isolation (Class I - General Controls, product code DRJ).
Submitted by Honeywell, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1977, 8 days after receiving the submission on September 6, 1977.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2600.
| 510(k) Number | K771684 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 06, 1977 |
| Decision Date | September 14, 1977 |
| Days to Decision | 8 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DRJ — System, Signal Isolation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 870.2600 |