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510(k) K800179

INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR by Sphygmetrics, Inc. — Product Code DXW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1980
Date Received
January 29, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Phonocatheter, Intracavitary
Device Class
Class II
Regulation Number
870.1270
Review Panel
CV
Submission Type

Other clearances by Sphygmetrics, Inc.

  • K800401 — INFRASONDE D4000 ELECTRONIC B-P MONITOR (March 12, 1980)

Other clearances for product code DXW

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  • K955887 — NEWMED ABP-LITE (September 5, 1996)
  • K802830 — MILLAR MIKRO-TIP CATHETER PHONOTRANS (December 10, 1980)
  • K800222 — MODEL 412 ELECTROFLUIDIC MANOMETER (February 29, 1980)