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510(k) K792001

COMFICARE PAD (FOR SINGEL PT USE) by Hamilton Industries, Inc. — Product Code FNM

K792001 is an FDA 510(k) premarket notification submitted by Hamilton Industries, Inc. for the device "COMFICARE PAD (FOR SINGEL PT USE)". The FDA issued a decision of Substantially Equivalent on October 26, 1979. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Hamilton Industries, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1979
Date Received
October 5, 1979
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 Hamilton Industries, Inc.

  • K883680 — MEDALIST EXAMINATION TABLE (October 4, 1988)
  • K790871 — ENCLOSED CASE CART (May 14, 1979)
  • K770956 — PAS ANTI-EMBOLISM SYSTEM (September 12, 1977)
  • K771018 — TRANS 2000 (July 14, 1977)

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