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510(k) K760668

SELECTATEC SYSTEM by Medishield, Inc. — Product Code CAD

K760668 is an FDA 510(k) premarket notification submitted by Medishield, Inc. for the device "SELECTATEC SYSTEM". The FDA issued a decision of Substantially Equivalent on September 27, 1976. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Medishield, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1976
Date Received
September 17, 1976
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 Medishield, Inc.

  • K781103 — SPECTRASCAN (September 27, 1978)
  • K780645 — HMD-2000 BATTERY-POWERED MINI-DRILL, THE (May 3, 1978)
  • K780646 — AIR-PWOERED COLDRILL (April 28, 1978)
  • K780202 — MONOMER EVACUATION SYSTEM (February 21, 1978)
  • K770161 — MICROFENESTRATED HIP REPLACEMENT COMPON. (January 26, 1977)
  • K761020 — ANKLE (FREEMAN-SWANSON) (November 23, 1976)
  • K761021 — ANKLE INSTRUMENTS (FREEMAN-SWANSON) (November 23, 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