510(k) K883806
- Device
- Rocket Intrauterine Sound
- Applicant
- A & A MEDICAL, INC.
- 510(k) number
- K883806
- Product code
- HHM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-10-31
- Date received
- 1988-09-07
- Regulation
- 884.4530
- Classification name
- Sound, Uterine
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- K BERNBERG
- Address
- 31a Business Park Dr. Branford CT US 06405 06405
FDA Registration Numbers#
- 3003536766
- 1421879
- 3005809810
- 2521453
- 3008367216
- 1222780
- 3007597038
- 5906
- 3005067367
- 3008719017
- 2246552
- 3003032798
- 3008936260
- 3007773213
- 3011499367
- 3012226300
- 3002807115
- 2320762
- 3014615697
- 1054241
- 9611503
- 9610621
- 3045853999
- 3015173212
- 3010041511
- 3011371465
- 3015279199
- 8040179
- 9613079
- 3002090132
- 3043533459
- 9614062
- 1055236
- 9611283
- 3003334541
- 3011137372
- 3003968049
- 1421101
- 3013358456
- 3039414397
- 3005440795
- 3009513193
- 1043214
- 3007507973
- 3015895045
- 3003759558
- 3001620590
- 1055890
- 3008338766
- 2529846
- 3010353847
- 1450908
- 9610612
- 8010099
- 9610905
- 3002834291
- 3004598675
- 1424263
- 2511556
- 3006389770
- 3012551896
- 3008770252
- 2084346
- 3010829427
- 1720747
- 3010131137
- 3003644849
- 3004519921
- 3003431869
- 9612074
- 8040278
- 3001084743
- 3007728276
- 3001297506
- 1923569
- 3010699884
- 8043235
- 3008808049
- 8043496
- 3012267976
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HHM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011840 | CERVILENZ UTERINE MEASURING SOUND | Cervilenz, Inc. | 2001-08-10 |
| K935665 | INTRAUTERINE SOUND | Rocket of London, Ltd. | 1994-02-24 |
| K884684 | ROCKET INTRAUTERINE DEPTH SOUND | A & A Medical, Inc. | 1988-12-20 |
| 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 |