K760064 is an FDA 510(k) clearance for the CATHETER, THERMAL DILUTION, ANIMAL & PED. This device is classified as a Probe, Thermodilution (Class II - Special Controls, product code KRB).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on July 21, 1976, 35 days after receiving the submission on June 16, 1976.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1915.
| 510(k) Number | K760064 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 1976 |
| Decision Date | July 21, 1976 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | KRB — Probe, Thermodilution |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1915 |