510(k) K011840
- Device
- CERVILENZ UTERINE MEASURING SOUND
- Applicant
- CERVILENZ INC
- 510(k) number
- K011840
- Product code
- HHM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-10
- Date received
- 2001-06-12
- Regulation
- 884.4530
- Classification name
- Sound, Uterine
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUDY F GORDON
- Address
- 2 Delphinus Irvine CA US 92612 92612
FDA Registration Numbers#
- 3023657851
- 9611112
- 3005440795
- 1825146
- 3007507973
- 3004215117
- 3006410968
- 2431166
- 1421879
- 1056350
- 2511556
- 8040278
- 3002090132
- 8010099
- 3010041511
- 1923569
- 9611827
- 3014615697
- 3008338766
- 8040263
- 9681540
- 9611283
- 3010131137
- 3015173212
- 3007597038
- 3004598675
- 3005925370
- 3003968049
- 3004519921
- 3003759558
- 2320762
- 3003244954
- 1054241
- 3010699884
- 3012507533
- 3015895045
- 8040179
- 3008808049
- 3001297506
- 3027556548
- 3001620590
- 2521453
- 3015351976
- 3013358456
- 3024860690
- 3004001706
- 1836161
- 3004571672
- 1319639
- 3035708926
- 3003644849
- 1424263
- 1043214
- 3012551896
- 2529846
- 8044098
- 1820334
- 3012226300
- 9614062
- 8040884
- 9611062
- 9611503
- 3005813597
- 8043235
- 3003418325
- 3010829427
- 3003536766
- 1055236
- 9680254
- 3011137372
- 3010353847
- 3003032798
- 3011499367
- 8040233
- 1722447
- 3003334541
- 3003431869
- 2916714
- 3007773213
Source Documents#
Other 510(k) Records For Product Code HHM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935665 | INTRAUTERINE SOUND | Rocket of London, Ltd. | 1994-02-24 |
| K884684 | ROCKET INTRAUTERINE DEPTH SOUND | A & A Medical, Inc. | 1988-12-20 |
| K883806 | ROCKET INTRAUTERINE SOUND | A & A Medical, Inc. | 1988-10-31 |
| K870550 | TEFLON UTERINE SOUND | Cook Ob/Gyn | 1987-03-04 |
| K840380 | UTERINE SOUND | Intl. Medical Technologies, Inc. | 1984-04-30 |
| K831224 | AUGROS HYSTEROMETER | Axcan Scientific Corp. | 1983-10-28 |
| K802315 | UTERINE SOUND | Gynemetrics, Inc. | 1981-01-12 |
| K781766 | UTERINE SOUND, BURNETT DISPOSABLE | C.R. Bard, Inc. | 1978-12-07 |
| K760170 | INTRAUTERINE SOUND, PLASTIC DISPOSABLE | G.D. Searle and Co. | 1976-07-19 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases