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510(k) K914674

MICROAIR 3500 by Gsi Development Co. — Product Code IOQ

K914674 is an FDA 510(k) premarket notification submitted by Gsi Development Co. for the device "MICROAIR 3500". The FDA issued a decision of Substantially Equivalent on November 22, 1991. The device falls under product code IOQ (Bed, Flotation Therapy, Powered), a Class II device regulated under 21 CFR 890.5170. Gsi Development Co. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 1991
Date Received
October 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Flotation Therapy, Powered
Device Class
Class II
Regulation Number
890.5170
Review Panel
PM
Submission Type

Other clearances by Gsi Development Co.

  • K926456 — MICROAIR TURN-Q (March 24, 1993)
  • K893708 — FLUIDIZED AIR BED (June 22, 1989)
  • K884529 — MICROAIR FLUIDIZED AIR BED (November 18, 1988)

Other clearances for product code IOQ

  • K143414 — Hill-Rom Wireless Connectivity Module (March 10, 2015)
  • K122473 — TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE (June 3, 2013)
  • K973624 — NURSE'S AID PATIENT ROTATION SYSTEM (January 21, 1998)
  • K970363 — HYDROTEC LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970364 — AIRTEC2 LOW AIR LOSS THERAPY BED (November 17, 1997)
  • K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS) (August 26, 1997)
  • K964873 — SILKAIR LOW AIRLOSS THERAPY (July 3, 1997)
  • K970295 — FLEXICAIR EXLIPSE PLUS (May 16, 1997)
  • K943433 — TOTAL CONTACT SEAT RIPPLE SYSTEM (July 31, 1995)
  • K951001 — FLEXICAIR EXLIPSE (June 27, 1995)

FDA data resources