FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
K Number: K896031
·
Decision Jan 12, 1990
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
19
Applicant Total
23
Review Days
88
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Basic Information
- Device Name
- AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY)
- K Number
- K896031
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.1550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Concord/Portex
- Date Received
- October 16, 1989
- Decision Date
- January 12, 1990
- 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.
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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SONO-VU US(TM), MODIFICATION
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
MEGA AMNIOCENTESIS KIT
FDA 510(k)
FDA Class 1
·Obstetrics/Gynecology
Other Clearances by Concord/Portex
| K Number | Device Name | ||
|---|---|---|---|
| K923559 | STERI-CATH MDI | Oct 25, 1993 | Substantially Equivalent |
| K930218 | SUBCUTANEOUS TUNNELING NEEDLE AND HANDLES | Jul 27, 1993 | Substantially Equivalent |
| K924541 | EPIDURAL MINIPACK | Jul 9, 1993 | Unknown |
| K930286 | DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITS | Jun 22, 1993 | Unknown |
| K923127 | NEEDLE-PRO CARTRIDGE | Apr 29, 1993 | Substantially Equivalent |
| K923910 | HEAT MOISTURE CONDENSER | Jan 26, 1993 | Substantially Equivalent |
| K922749 | LOW PROFILE TRACHEOSTOMY TUBE | Sep 2, 1992 | Substantially Equivalent |
| K922445 | VACU-PRO | Aug 12, 1992 | Substantially Equivalent |
| K915452 | ANESTHESIA BREATHING CIRCUIT | Feb 14, 1992 | Substantially Equivalent |
| K911809 | NEW-VENT | Aug 26, 1991 | Substantially Equivalent |