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510(k) K800179

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

K800179 is an FDA 510(k) premarket notification submitted by Sphygmetrics, Inc. for the device "INFRASONDE AUTO/INFLATOR ELEC. VIBRATOR". The FDA issued a decision of Substantially Equivalent on February 11, 1980. The device falls under product code DXW (System, Phonocatheter, Intracavitary), a Class II device regulated under 21 CFR 870.1270. Sphygmetrics, Inc. has at least 1 other 510(k) clearance on record.

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

  • K972020 — OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR (May 5, 1998)
  • K955887 — NEWMED ABP-LITE (September 5, 1996)
  • K802830 — MILLAR MIKRO-TIP CATHETER PHONOTRANS (December 10, 1980)
  • K800222 — MODEL 412 ELECTROFLUIDIC MANOMETER (February 29, 1980)

FDA data resources