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510(k) K883256

BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM by Bio Clinic Co. — Product Code FNM

K883256 is an FDA 510(k) premarket notification submitted by Bio Clinic Co. for the device "BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 1988. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Bio Clinic Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1988
Date Received
August 2, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mattress, Air Flotation, Alternating Pressure
Device Class
Class II
Regulation Number
880.5550
Review Panel
HO
Submission Type

Other clearances by Bio Clinic Co.

  • K930791 — AMERICAN POWER CONVERSIONS, BACK-UPS 600 (August 6, 1993)
  • K932480 — PRISM (July 21, 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)
  • K921211 — NOW PREGNANCY TEST KIT (May 7, 1992)
  • K921212 — MIRCO ELISA HPL TEST KIT (May 7, 1992)
  • K920921 — ELISA TUBE PROLACTIN TEST KIT (April 8, 1992)
  • K920920 — ELISA TUBE LH TEST KIT (April 8, 1992)
  • K920918 — TMB CHROMOGEN/SUBSTRATE REAGENT SET (April 7, 1992)

Other clearances for product code FNM

  • K973169 — PRESSURE GUARD SITE SELECT (A) (February 20, 1998)
  • K974319 — MIGHTY AIR (January 22, 1998)
  • K972022 — ZAK-2000 (January 22, 1998)
  • K974070 — PHYSIO/1000 (January 6, 1998)
  • K972549 — SIMPULSE (November 18, 1997)
  • K970081 — SUPER AIR 9000 ALTERNATING AIR FLOATATION MATTRESS SYSTEM (November 7, 1997)
  • K955243 — BARIAIR (October 23, 1997)
  • K970468 — KT AIR BED (September 5, 1997)
  • K965207 — RID-DECUBE II (August 21, 1997)
  • K972153 — ALTERNATING PRESSURE AIR FLOTATION MATTRESS (July 31, 1997)

FDA data resources