Submission Details
| 510(k) Number | K011840 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 12, 2001 |
| Decision Date | August 10, 2001 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
Cleared
Traditional
CERVILENZ UTERINE MEASURING SOUND
Aug 2001
Decision
59d
Days
Class 1
Risk
About This 510(k) Submission
K011840 is an FDA 510(k) clearance for the CERVILENZ UTERINE MEASURING SOUND, a Sound, Uterine (Class I — General Controls, product code HHM), submitted by Cervilenz, Inc. (Irvine, US). The FDA issued a Cleared decision on August 10, 2001, 59 days after receiving the submission on June 12, 2001. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.
Device Classification
| Product Code | HHM — Sound, Uterine |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 884.4530 |
Manufacturer
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