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510(k) K924973

DYLNAMEDICS A.S.A.P. by Dynamedics, Inc. — Product Code INX

K924973 is an FDA 510(k) premarket notification submitted by Dynamedics, Inc. for the device "DYLNAMEDICS A.S.A.P.". The FDA issued a decision of Substantially Equivalent on October 15, 1993. The device falls under product code INX (Bed, Air Fluidized), a Class II device regulated under 21 CFR 890.5160. Dynamedics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1993
Date Received
September 30, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Air Fluidized
Device Class
Class II
Regulation Number
890.5160
Review Panel
PM
Submission Type

Other clearances by Dynamedics, Inc.

  • K873979 — DYNAMARK 1000 (November 27, 1987)

Other clearances for product code INX

  • K972176 — HOME CARE BEAD BED (January 16, 1998)
  • K964223 — CLINITRON RITE-HITE (May 28, 1997)
  • K943385 — CLINITRON ELEXIS (February 27, 1995)
  • K942184 — CLINITRON AT HOME AIR FLUIDED THERAPY (February 7, 1995)
  • K931168 — X-20 AIR SUPPORT BED (February 17, 1994)
  • K934689 — LOW AIR LOSS MATTRESS, MODIFICATION (February 2, 1994)
  • K926402 — COMFORT CARE LOW AIR LOSS THERAPY BED (March 24, 1993)
  • K924686 — REM-AIR (February 12, 1993)
  • K920112 — CLINITRON C-II (January 24, 1992)
  • K913654 — SMITH AND DAVIS PRESSURE THERAPY SYSTEM (November 22, 1991)

FDA data resources