The following data is part of a premarket notification filed by Cervilenz Inc with the FDA for Cervilenz Uterine Measuring Sound.
| Device ID | K011840 |
| 510k Number | K011840 |
| Device Name: | CERVILENZ UTERINE MEASURING SOUND |
| Classification | Sound, Uterine |
| Applicant | CERVILENZ INC 2 DELPHINUS Irvine, CA 92612 |
| Contact | Judy F Gordon |
| Correspondent | Judy F Gordon CERVILENZ INC 2 DELPHINUS Irvine, CA 92612 |
| Product Code | HHM |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-12 |
| Decision Date | 2001-08-10 |
| Summary: | summary |