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510(k) K934385

MINIPACK 3100/3000 MODIFICATION by Pace Tech, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1994
Date Received
September 9, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Pace Tech, Inc.

  • K951226 — VITALMAX 4000/MINIPACK 3100/3000 (November 21, 1996)
  • K953795 — VITALMAX 4100 (July 1, 1996)
  • K944541 — HANDYPACK 911SC (February 22, 1995)
  • K945385 — VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 (January 31, 1995)
  • K925701 — MINIPACK 911-STC (August 11, 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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