Home / 510(k) Clearances / K780502

510(k) K780502

NOVA AIR FLOATATION SYSTEM by Nova Health Systems, Inc. — Product Code FNM

K780502 is an FDA 510(k) premarket notification submitted by Nova Health Systems, Inc. for the device "NOVA AIR FLOATATION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 10, 1978. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Nova Health Systems, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1978
Date Received
March 29, 1978
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 Nova Health Systems, Inc.

  • K895477 — NOVA PILLOW (January 10, 1990)
  • K893713 — NOVA OXYGEN TENT (August 21, 1989)

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