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510(k) K951469

BAZOOKA SYSTEM by Innovative Medical Systems, Inc. — Product Code FNM

K951469 is an FDA 510(k) premarket notification submitted by Innovative Medical Systems, Inc. for the device "BAZOOKA SYSTEM". The FDA issued a decision of Substantially Equivalent on June 28, 1995. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Innovative Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1995
Date Received
March 30, 1995
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 Innovative Medical Systems, Inc.

  • K973035 — VIOLA II DENTAL CAMERA SYSTEM (September 24, 1997)
  • K933184 — POSITIVE AIRWAY PRESSURE SYSTEM (November 28, 1994)
  • K924590 — MICROWAVE AUTOMATED TISSUE PROCESSOR (December 29, 1992)
  • K922081 — LABOTECH AUTOMATED MICROTITER ANALYZER (September 2, 1992)
  • K921005 — AUTOLOADER (April 29, 1992)
  • K915457 — PHACO 20/20 SYSTEM I (February 24, 1992)
  • K915456 — PHACO 3000 LINEAR (February 12, 1992)
  • K883599 — LX-80 AUTOMATED TISSUE PROCESSOR (PLASTIC) (September 2, 1988)
  • K880745 — LX-100 SLIDE STAINER (April 27, 1988)
  • K853938 — LX 300 TISSUE PROCESSOR (October 10, 1985)

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