K830898 is an FDA 510(k) clearance for the SYRINGE 500BC BE #7000. This device is classified as a Calibrator, Volume, Gas (Class I - General Controls, product code BXW).
Submitted by Instrumentation Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1983, 56 days after receiving the submission on March 21, 1983.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1870.
| 510(k) Number | K830898 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1983 |
| Decision Date | May 16, 1983 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | BXW — Calibrator, Volume, Gas |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.1870 |