FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SONO-VU US(TM), MODIFICATION
K Number: K921738
·
Decision Apr 27, 1992
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
19
Applicant Total
56
Review Days
89
Basic Information
- Device Name
- SONO-VU US(TM), MODIFICATION
- K Number
- K921738
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.1550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- E-Z-EM, INC.
- Date Received
- January 29, 1992
- Decision Date
- April 27, 1992
- Product Code
- HIO
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIO), ordered by most recent decision date.
G.E. STERILE AMNIOCENTESIS TRAY
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RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY
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AMNIOTEST(TM)
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VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE
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MEGA AMNIOCENTESIS KIT
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FDA Class 1
·Obstetrics/Gynecology
SONO-VU US(TM)
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by E-Z-EM, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K071378 | MODIFICATION TO EMPOWER CT/CTA INJECTOR SYSTEM, MODELS 9800/9900 PRODUCT SERIES | Jun 13, 2007 | Substantially Equivalent |
| K062449 | EMPOWERMR INJECTOR SYSTEM, MODEL 9730 | Apr 13, 2007 | Substantially Equivalent |
| K063029 | EMPOWER CT/CTA INJECTOR SYSTEM, MODEL 9800/9900 | Nov 2, 2006 | Substantially Equivalent |
| K053008 | E-Z-EM ENDOSCOPIC CO2 REGULATOR | Dec 27, 2005 | Substantially Equivalent |
| K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) | Jul 16, 2004 | Substantially Equivalent |
| K031571 | EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 | Jun 19, 2003 | Substantially Equivalent |
| K030854 | PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400 | Apr 16, 2003 | Substantially Equivalent |
| K013219 | PROTOCO2L INSUFFLATOR MODEL 6400 | Feb 19, 2002 | Substantially Equivalent |
| K011160 | E-Z EM PERCUPUMP 2001 CT INJECTOR | May 16, 2001 | Substantially Equivalent |
| K974621 | PERCUPUMP II WITH EDA | Jan 27, 1998 | Substantially Equivalent |