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510(k) K970046

UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550) by Accutron, Inc. — Product Code KHA

K970046 is an FDA 510(k) premarket notification submitted by Accutron, Inc. for the device "UNIVERSAL LOW PROFILE NASAL HOODS(1250,1275,1350,1450,1475,1550)". The FDA issued a decision of Substantially Equivalent on March 28, 1997. The device falls under product code KHA (Mask, Scavenging), a Class I device regulated under 21 CFR 868.5590. Accutron, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 1997
Date Received
January 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Scavenging
Device Class
Class I
Regulation Number
868.5590
Review Panel
AN
Submission Type

Other clearances by Accutron, Inc.

  • K052335 — ANALGESIA GAS MACHINE, MODEL DIGITAL ULTRA (November 23, 2005)
  • K033503 — RFS VACUUM GAUGE SCAVENGING CIRCUIT (March 12, 2004)
  • K992421 — GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 (October 27, 1999)
  • K965239 — PIP LOW PROFILE SCAVENGING SYSTEM(260 AND 261)/UNIVERSAL LOW PROFILE SCAVENGING (March 28, 1997)

FDA data resources