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510(k) K970688

POCKET RESCUE by Cheen Houng Ent. Co. , Ltd. — Product Code KGB

K970688 is an FDA 510(k) premarket notification submitted by Cheen Houng Ent. Co. , Ltd. for the device "POCKET RESCUE". The FDA issued a decision of Substantially Equivalent on September 26, 1997. The device falls under product code KGB (Mask, Oxygen, Non-Rebreathing), a Class I device regulated under 21 CFR 868.5570. Cheen Houng Ent. Co. , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1997
Date Received
February 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Oxygen, Non-Rebreathing
Device Class
Class I
Regulation Number
868.5570
Review Panel
AN
Submission Type

Other clearances by Cheen Houng Ent. Co. , Ltd.

  • K121587 — BREATH SHAKE (November 22, 2013)
  • K021390 — PMX COMPACT RESUCITATOR (October 4, 2002)
  • K003927 — Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 (June 26, 2001)
  • K010191 — Y2000 POCKET RESCUE (March 14, 2001)
  • K981415 — 0-20 CM H20 PEEP VALVE (July 14, 1998)

Other clearances for product code KGB

  • K960401 — ULTIMATE SEAL (June 20, 1996)
  • K941336 — COMBO MASK (September 9, 1994)
  • K935917 — CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES (February 4, 1994)
  • K932347 — COMPACT MASK (January 10, 1994)
  • K933583 — NONREBREATHING VALVE (January 3, 1994)
  • K933048 — LAERDAL(TM) POCKET MASK, MODIFICATION (December 2, 1993)
  • K930336 — PROFAST(R)-DENTURE ADHESIVE CREAM (August 24, 1993)
  • K913164 — NON REBREATHING MASK (January 15, 1992)
  • K883766 — MOUTH-TO-MASK VENTILATORY ADJUNCT (October 21, 1988)
  • K790162 — OXYGEN MASK, CONCENTRATION AEROSOL MASK (April 20, 1979)

FDA data resources