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510(k) K945482

DISPOSABLE, CPAP OXYGEN MASK by Fvtnks — Product Code BYG

K945482 is an FDA 510(k) premarket notification submitted by Fvtnks for the device "DISPOSABLE, CPAP OXYGEN MASK". The FDA issued a decision of Substantially Equivalent on September 19, 1995. The device falls under product code BYG (Mask, Oxygen), a Class I device regulated under 21 CFR 868.5580. Fvtnks has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1995
Date Received
November 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen
Device Class
Class I
Regulation Number
868.5580
Review Panel
AN
Submission Type

Other clearances by Fvtnks

  • K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (November 8, 1994)
  • K940544 — DOUBLE TRACH SEIVEL CONNECTOR (April 19, 1994)
  • K935713 — WILEY/ESPOSITO DENTAL GUARD (January 5, 1994)

Other clearances for product code BYG

  • K963298 — FIRST AID KIT(S) (November 6, 1996)
  • K962848 — HANS RUDOLPH NASAL CPAP MASK (October 16, 1996)
  • K953464 — WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK (September 18, 1995)
  • K953039 — VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKS (September 15, 1995)
  • K945472 — WESTMED PEDIATRIC AND ADULT AEROSOL MASK (February 7, 1995)
  • K942907 — JEMSDAL MASK (August 31, 1994)
  • K940887 — SYSTEM 22 ADULT MASK (April 19, 1994)
  • K940888 — SYSTEM 22 PAEDIATRIC MASK (April 19, 1994)
  • K931952 — MEDWAY OXYGEN MASK (August 20, 1993)
  • K924069 — SURGICO OXYGEN MASK (February 4, 1993)

FDA data resources