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510(k) K791189

ECHO CARDIOGRAM PAD by Alimed, Inc. — Product Code FNJ

K791189 is an FDA 510(k) premarket notification submitted by Alimed, Inc. for the device "ECHO CARDIOGRAM PAD". The FDA issued a decision of Substantially Equivalent on July 17, 1979. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120. Alimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1979
Date Received
June 26, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Manual
Device Class
Class I
Regulation Number
880.5120
Review Panel
HO
Submission Type

Other clearances by Alimed, Inc.

  • K963527 — UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS (October 31, 1996)
  • K963528 — ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STR (October 29, 1996)
  • K963526 — STRAP WEDGE (October 28, 1996)
  • K920487 — MINI VIBRATOR (February 18, 1992)
  • K840156 — PROTECTA COAT SPONGES (March 23, 1984)
  • K822650 — SUPER DONUT (September 30, 1982)
  • K822651 — TOTAL FINGER FLEXION SPLINT (September 17, 1982)
  • K820516 — ARTERIAL CANALIZATION DEVICE (April 15, 1982)
  • K820517 — CONSTRUCTA FOAM (March 10, 1982)
  • K801743 — PLASTAZOTE SHOE (August 7, 1980)

Other clearances for product code FNJ

  • K934298 — KING KRIB (January 26, 1994)
  • K892877 — CRADLE, HOSPITAL BED CLOTHING (June 15, 1989)
  • K885241 — BED, ADJUSTABLE, HOSPITAL, FOLDING, FIELD, W/O MAT (February 24, 1989)
  • K884542 — SIC 3999 FOLDING ADJUSTABLE HOSPITAL BED (November 21, 1988)
  • K881725 — ENVIROTENT (BED) (November 8, 1988)
  • K881961 — MSI STANDARD BED MODELS: L1097-64 AND L1085-64 (November 1, 1988)
  • K881964 — MSI 3003 SERIES BED (June 28, 1988)
  • K881962 — MSI 2005 SERIES BED (June 3, 1988)
  • K881043 — FOLDING HOSPITAL COT NSN 6530-00-299-8517 (April 12, 1988)
  • K870166 — PLATFORM MATTRESS W/DISPOSABLE BEDPAN BAG (March 13, 1987)

FDA data resources