Submission Details
| 510(k) Number | K883334 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 09, 1988 |
| Decision Date | December 15, 1988 |
| Days to Decision | 128 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
Cleared
Traditional
K883334 - BIODOP(TM)
(FDA 510(k) Clearance)
Dec 1988
Decision
128d
Days
Class 2
Risk
K883334 is an FDA 510(k) clearance for the BIODOP(TM). This device is classified as a Monitor, Heart Sound, Fetal, Ultrasonic (Class II — Special Controls, product code HEK).
Submitted by Diagnosis Related Systems, Inc. (Hialeah, US). The FDA issued a Cleared decision on December 15, 1988, 128 days after receiving the submission on August 9, 1988.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.2660.
Device Classification
| Product Code | HEK — Monitor, Heart Sound, Fetal, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.2660 |
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