FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PMS AMNIOCENTESIS TRAY/KIT
K Number: K850632
·
Decision May 22, 1985
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
19
Applicant Total
19
Review Days
92
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Basic Information
- Device Name
- PMS AMNIOCENTESIS TRAY/KIT
- K Number
- K850632
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.1550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Professional Medical Services
- Date Received
- February 19, 1985
- Decision Date
- May 22, 1985
- Product Code
- HIO
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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.
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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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SONO-VU US(TM), MODIFICATION
FDA 510(k)
FDA Class 1
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MEGA AMNIOCENTESIS KIT
FDA 510(k)
FDA Class 1
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Other Clearances by Professional Medical Services
| K Number | Device Name | ||
|---|---|---|---|
| K913094 | DISPOSABLE SLIDE VALVE MANIFOLD | Jan 27, 1992 | Substantially Equivalent |
| K910378 | PRESSURE MONITORING EXTENSION LINE | Apr 22, 1991 | Substantially Equivalent |
| K904508 | CONDOR ANALOG INFLATION SYRINGE | Apr 2, 1991 | Substantially Equivalent |
| K904954 | CONDOR DIGITAL INFLATION SYRINGE | Jan 16, 1991 | Substantially Equivalent |
| K902606 | RADIOPAQUE RULER | Sep 27, 1990 | Substantially Equivalent |
| K884577 | PROCEDURE READY TRAYS | Aug 1, 1989 | Unknown |
| K890471 | PMS ANGIO DRAPE | Feb 27, 1989 | Substantially Equivalent |
| K884497 | CONTROL SYRINGE | Dec 12, 1988 | Substantially Equivalent |
| K872448 | BLOOD CONTAINMENT PACK | Nov 17, 1987 | Substantially Equivalent |
| K864555 | 3 RING ATTACHMENT | Dec 1, 1986 | Substantially Equivalent |