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510(k) K922960

VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE by Cameo, Inc. — Product Code HIO

K922960 is an FDA 510(k) premarket notification submitted by Cameo, Inc. for the device "VARIOUS CAMEO MED AMNIOCENTESIS TRAYS, DISPOSABLE". The FDA issued a decision of Substantially Equivalent (kit, denovo) on November 5, 1992. The device falls under product code HIO (Sampler, Amniotic Fluid (Amniocentesis Tray)), a Class I device regulated under 21 CFR 884.1550. Cameo, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
November 5, 1992
Date Received
June 18, 1992
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 Cameo, Inc.

  • K922961 — VARIOUS CAMEO MED PERCUTANEOUS SKIN PREP TRAYS, (March 23, 1993)
  • K922962 — VARIOUS CAMEO MED BASIC BIOPSY TRAYS, DISPOSABLE (March 23, 1993)

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)
  • 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)
  • K894031 — PHARMASEAL GENETIC AMNIOCENTESIS TRAY (August 4, 1989)

FDA data resources