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510(k) K934817

SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS by Surgical Design Corp. — Product Code FNM

K934817 is an FDA 510(k) premarket notification submitted by Surgical Design Corp. for the device "SURGICAL DESIGN CORPORATION MODEL 700 LOW PRESSURE MATTRESS". The FDA issued a decision of Substantially Equivalent on June 17, 1994. The device falls under product code FNM (Mattress, Air Flotation, Alternating Pressure), a Class II device regulated under 21 CFR 880.5550. Surgical Design Corp. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1994
Date Received
October 5, 1993
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 Surgical Design Corp.

  • K043533 — SURGICAL DESIGN CIRCUMCISION CLAMP (April 1, 2005)
  • K991852 — OCUSYSTEM ART ADVANTAGE, MODEL 995 (July 7, 1999)
  • K961243 — OCUSYSTEM ART ADVANTAGE (July 10, 1996)

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