K830781 is an FDA 510(k) clearance for the ENDO-GUARD. This device is classified as a Hood, Oxygen, Infant (Class I - General Controls, product code FOG).
Submitted by Jayco Pharmaceuticals (Mchenry, US). The FDA issued a Cleared decision on March 31, 1983, 20 days after receiving the submission on March 11, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5700.
| 510(k) Number | K830781 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 11, 1983 |
| Decision Date | March 31, 1983 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | FOG — Hood, Oxygen, Infant |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5700 |