Submission Details
| 510(k) Number | K860516 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 11, 1986 |
| Decision Date | February 21, 1986 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K860516 is an FDA 510(k) clearance for the LSP MINILATOR, a Flowmeter, Calibration, Gas (Class I — General Controls, product code BXY), submitted by Life Support Products, Inc. (Irvine, US). The FDA issued a Cleared decision on February 21, 1986, 10 days after receiving the submission on February 11, 1986. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2350.
| 510(k) Number | K860516 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 11, 1986 |
| Decision Date | February 21, 1986 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BXY — Flowmeter, Calibration, Gas |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.2350 |