K851904 is an FDA 510(k) clearance for the DATA TRAC ANESTHESIOLOGY RECORDER. This device is classified as a Infusor, Pressure, For I.v. Bags (Class I - General Controls, product code KZD).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on May 10, 1985, 10 days after receiving the submission on April 30, 1985.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5420.
| 510(k) Number | K851904 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1985 |
| Decision Date | May 10, 1985 |
| Days to Decision | 10 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | - |
| Product Code | KZD - Infusor, Pressure, For I.v. Bags |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5420 |