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510(k) K850632

PMS AMNIOCENTESIS TRAY/KIT by Professional Medical Services — Product Code HIO

K850632 is an FDA 510(k) premarket notification submitted by Professional Medical Services for the device "PMS AMNIOCENTESIS TRAY/KIT". The FDA issued a decision of Substantially Equivalent on May 22, 1985. The device falls under product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)), a Class I device regulated under 21 CFR 884.1550. Professional Medical Services has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1985
Date Received
February 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sampler, Amniotic Fluid (Amniocentesis Tray)
Device Class
Class I
Regulation Number
884.1550
Review Panel
OB
Submission Type

Other clearances by Professional Medical Services

  • K913094 — DISPOSABLE SLIDE VALVE MANIFOLD (January 27, 1992)
  • K910378 — PRESSURE MONITORING EXTENSION LINE (April 22, 1991)
  • K904508 — CONDOR ANALOG INFLATION SYRINGE (April 2, 1991)
  • K904954 — CONDOR DIGITAL INFLATION SYRINGE (January 16, 1991)
  • K902606 — RADIOPAQUE RULER (September 27, 1990)
  • K884577 — PROCEDURE READY TRAYS (August 1, 1989)
  • K890471 — PMS ANGIO DRAPE (February 27, 1989)
  • K884497 — CONTROL SYRINGE (December 12, 1988)
  • K872448 — BLOOD CONTAINMENT PACK (November 17, 1987)
  • K864555 — 3 RING ATTACHMENT (December 1, 1986)

Other clearances for product code HIO

  • K960203 — G.E. STERILE AMNIOCENTESIS TRAY (March 14, 1996)
  • K955679 — RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY (March 12, 1996)
  • K914419 — AMNIOTEST(TM) (September 1, 1993)
  • K922960 — VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE (November 5, 1992)
  • K921738 — SONO-VU US(TM), MODIFICATION (April 27, 1992)
  • K915863 — MEGA AMNIOCENTESIS KIT (March 30, 1992)
  • K904583 — SONO-VU US(TM) (June 24, 1991)
  • K901643 — ISOFLO(TM) AMNIOCENTESIS TRAY (July 25, 1990)
  • K900021 — PERCU-SET(TM) (March 29, 1990)
  • K896031 — AMNIOTIC FLUID SAMPLER (AMNIOCENTESIS TRAY) (January 12, 1990)

FDA data resources