K924709 is an FDA 510(k) clearance for the SATCARE OXYGEN CONTROLLER/MONITOR W/ PULSE OXIMETE. This device is classified as a Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (Class II - Special Controls, product code KLK).
Submitted by Air-Shields, Inc. (Hatboro, US). The FDA issued a Cleared decision on January 17, 1996, 1216 days after receiving the submission on September 18, 1992.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2500.
| 510(k) Number | K924709 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 1992 |
| Decision Date | January 17, 1996 |
| Days to Decision | 1216 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | KLK — Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.2500 |