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510(k) K864667

PENOX HOSPITAL BED by Penox Technologies, Inc. — Product Code FNJ

K864667 is an FDA 510(k) premarket notification submitted by Penox Technologies, Inc. for the device "PENOX HOSPITAL BED". The FDA issued a decision of Substantially Equivalent on January 21, 1987. The device falls under product code FNJ (Bed, Manual), a Class I device regulated under 21 CFR 880.5120. Penox Technologies, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1987
Date Received
December 2, 1986
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 Penox Technologies, Inc.

  • K863978 — PORTABLE LIQUID OXYGEN UNIT (MODIFICATION) (December 15, 1986)
  • K862654 — MODIFIED PENOX LIFT CHAIR (July 18, 1986)
  • K853775 — PENOX HIGH FLOW MANIFOLD (November 29, 1985)
  • K852109 — PENOX PERFORMER WHEELCHAIR (August 22, 1985)
  • K851218 — PENOX LIFT CHAIR (June 21, 1985)
  • K851219 — FILL HOSE SAFETY ADAPTER (June 18, 1985)
  • K851216 — PENOX DUAL FEED MANIFOLD (June 18, 1985)
  • K851215 — T-HANDLE ADAPTER, U-HANDLE & L HANDLER ADAPTER (June 18, 1985)
  • K851217 — PENOX DUAL FLOW MINIFOLD (June 18, 1985)

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