K834057 is an FDA 510(k) clearance for the IL 301 PORTABLE TRANSCUT. OXYGEN MONI. This device is classified as a Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (Class II - Special Controls, product code KLK).
Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984, 73 days after receiving the submission on November 23, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2500.
| 510(k) Number | K834057 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1983 |
| Decision Date | February 04, 1984 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2500 |