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510(k) K944541

HANDYPACK 911SC by Pace Tech, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1995
Date Received
September 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Pace Tech, Inc.

  • K951226 — VITALMAX 4000/MINIPACK 3100/3000 (November 21, 1996)
  • K953795 — VITALMAX 4100 (July 1, 1996)
  • K945385 — VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 (January 31, 1995)
  • K925701 — MINIPACK 911-STC (August 11, 1994)
  • K934385 — MINIPACK 3100/3000 MODIFICATION (August 10, 1994)
  • K933624 — VITALMAX 4000 (July 19, 1994)
  • K930559 — VITALMAX 800-C (September 3, 1993)
  • K912835 — MINI-PACK 911 SERIES (February 3, 1992)
  • K912880 — VITALMAX 510/520 (November 14, 1991)
  • K913263 — VITALMAX 830 SERIES (October 10, 1991)

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