Submission Details
| 510(k) Number | K884927 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 28, 1988 |
| Decision Date | June 23, 1989 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
K884927 is an FDA 510(k) clearance for the BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on June 23, 1989, 207 days after receiving the submission on November 28, 1988. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.
| 510(k) Number | K884927 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 28, 1988 |
| Decision Date | June 23, 1989 |
| Days to Decision | 207 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAN — Regulator, Pressure, Gas Cylinder |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 868.2700 |