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510(k) K932480

PRISM by Bio Clinic Co. — Product Code IOQ

K932480 is an FDA 510(k) premarket notification submitted by Bio Clinic Co. for the device "PRISM". The FDA issued a decision of Substantially Equivalent on July 21, 1993. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Bio Clinic Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1993
Date Received
May 24, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Flotation Therapy, Powered
Device Class
Class II
Regulation Number
890.5170
Review Panel
PM
Submission Type

Other clearances by Bio Clinic Co.

  • K930791 — AMERICAN POWER CONVERSIONS, BACK-UPS 600 (August 6, 1993)
  • K926189 — ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALE (June 24, 1993)
  • K921958 — ELISA TUBE TSH TEST (July 2, 1992)
  • K922140 — ORTHODERM CONVERTIBLE II (May 27, 1992)
  • K921212 — MIRCO ELISA HPL TEST KIT (May 7, 1992)
  • K921211 — NOW PREGNANCY TEST KIT (May 7, 1992)
  • K920920 — ELISA TUBE LH TEST KIT (April 8, 1992)
  • K920921 — ELISA TUBE PROLACTIN TEST KIT (April 8, 1992)
  • K920918 — TMB CHROMOGEN/SUBSTRATE REAGENT SET (April 7, 1992)
  • K920917 — ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY (March 26, 1992)

Other clearances for product code IOQ

  • K143414 — Hill-Rom Wireless Connectivity Module (March 10, 2015)
  • K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE (June 3, 2013)
  • K973624 — NURSE'S AID PATIENT ROTATION SYSTEM (January 21, 1998)
  • K970363 — HYDROTEC LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970364 — AIRTEC2 LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (August 26, 1997)
  • K964873 — SILKAIR LOW AIRLOSS THERAPY (July 3, 1997)
  • K970295 — FLEXICAIR EXLIPSE PLUS (May 16, 1997)
  • K943433 — TOTAL CONTACT SEAT RIPPLE SYSTEM (July 31, 1995)
  • K951001 — FLEXICAIR EXLIPSE (June 27, 1995)

FDA data resources