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510(k) K770021

MASK, FACE, SURGICAL by Precept, Inc. — Product Code CAD

K770021 is an FDA 510(k) premarket notification submitted by Precept, Inc. for the device "MASK, FACE, SURGICAL". The FDA issued a decision of Substantially Equivalent on January 17, 1977. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Precept, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 1977
Date Received
January 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vaporizer, Anesthesia, Non-Heated
Device Class
Class II
Regulation Number
868.5880
Review Panel
AN
Submission Type

Other clearances by Precept, Inc.

  • K771409 — DISP. SURGICAL FACE MASK (October 27, 1977)
  • K770463 — MASK, SURGICAL, FACE, DISPOSABLE (March 23, 1977)
  • K770391 — COVER, ARMBOARD, DISPOSABLE (March 7, 1977)
  • K760360 — SHIRT, MITTEN CUFF INFANT (October 20, 1976)

Other clearances for product code CAD

  • K240375 — V80 Anesthetic Vaporizer (V80) (October 31, 2024)
  • K172702 — Tec 820, Tec 850 (January 4, 2018)
  • K150167 — V60 Anesthetic Vaporizer (June 30, 2015)
  • K110608 — SEVOFLURANE VAPORIZER ADAPTOR (July 20, 2011)
  • K060331 — SIGMA ALPHA VAPORIZER (May 10, 2006)
  • K053564 — KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 (March 3, 2006)
  • K051666 — GAV - GENERAL ANAESTHETIC VAPORIZER (August 23, 2005)
  • K042276 — D-VAPOR (September 23, 2004)
  • K041076 — DELTA T (August 9, 2004)
  • K031027 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) (June 26, 2003)

FDA data resources