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510(k) K970163

ALPHA MX (20)/ULTRA PC (30) by Technical Medical Products, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 1997
Date Received
January 16, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
Review Panel
AN
Submission Type

Other clearances by Technical Medical Products, Inc.

  • K896510 — TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR. (January 22, 1990)
  • K884167 — TECH MED NITROUS OXIDE SEDATION NASAL INHALER CIR. (October 28, 1988)

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