510(k) K860233
- Device
- 5 Mhz Intracavitary Probe, Model H4222v
- Applicant
- GENERAL ELECTRIC CO.
- 510(k) number
- K860233
- Product code
- HEM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-06-02
- Date received
- 1986-01-22
- Regulation
- 884.2225
- Classification name
- Imager, Ultrasonic Obstetric-Gynecologic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- HOWARD II
- Address
- P.O. Box 414 Milwaukee WI US 53201 53201
FDA Registration Numbers#
- 3007766601
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HEM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951393 | ABACUS OB ULTRASOUNG COMPUTER SOFTWARE | Solomon Technology Labs | 1995-05-01 |
| K942490 | BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND | Medical Soft, Inc. | 1995-02-15 |
| K910426 | SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT | Shimadzu Medical Systems | 1991-06-06 |
| K905000 | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER | Corometrics Medical Systems, Inc. | 1991-01-31 |
| K900505 | SONOACE 88 PORTABLE ULTRASOUND SCANNER | Medison Co., Ltd. | 1990-08-10 |
| K900271 | MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK | Digisonics, Inc. | 1990-04-19 |
| K890637 | EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE | Elscint, Inc. | 1989-06-12 |
| K881329 | FETAL DOPPLER FOR ULTRAMARK 4 AND 8 | Advanced Technology Laboratories, Inc. | 1989-04-14 |
| K885061 | SIEMENS INTRAVAGINAL TRANSDUCER | Siemens Medical Solutions USA, Inc. | 1989-02-23 |
| K881185 | ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. | Philips Medical Systems (Cleveland), Inc. | 1988-06-01 |
| K880900 | SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER | Corometrics Medical Systems, Inc. | 1988-06-01 |
| K862364 | NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) | Swemed Laboratories, Inc. | 1986-08-19 |
| K862627 | SONORANGER TRANSVAGINAL PROBE | Ausonics Pty , Ltd. | 1986-08-01 |
| K861931 | 645OB SECTOR/LINEAR ULTRASOUND SCANNER | Ge Medical Systems Information Technologies | 1986-07-31 |
| K853711 | 5.0 MHZ INTRACAVITARY SECTOR PROBE | General Electric Co. | 1985-12-18 |