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510(k) K881264

PERMA PURE NAFION TUBE DRYER-MODEL ME by Perma Pure Products, Inc. — Product Code CBQ

K881264 is an FDA 510(k) premarket notification submitted by Perma Pure Products, Inc. for the device "PERMA PURE NAFION TUBE DRYER-MODEL ME". The FDA issued a decision of Substantially Equivalent on October 25, 1988. The device falls under product code CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)), a Class II device regulated under 21 CFR 868.1500.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1988
Date Received
March 24, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class
Class II
Regulation Number
868.1500
Review Panel
AN
Submission Type

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  • K962648 — OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR (January 17, 1997)
  • K931439 — OHMEDA MODEL 5330 ANESTHETIC MONITOR (October 19, 1993)
  • K926451 — DATASCOPE MULTINEX II (August 25, 1993)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 1993)
  • K922876 — AS/3 COP MODULE (July 21, 1993)
  • K923276 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (July 21, 1993)
  • K930303 — DATASCOPE MULTINEX ID PLUS (June 16, 1993)
  • K914295 — ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED (April 10, 1992)

FDA data resources