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510(k) K792283

ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON by Arzbaecher & Co. — Product Code DRR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 1979
Date Received
November 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Amplifier And Signal Conditioner, Biopotential
Device Class
Class II
Regulation Number
870.2050
Review Panel
CV
Submission Type

Other clearances by Arzbaecher & Co.

  • K800201 — ESOPHAGEAL PILL-ELECTRODE (February 26, 1980)

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  • K910307 — CARDIOLAB AMPLIFIER MODULE (CAM) (April 12, 1991)
  • K894735 — ASC-952 PHYSIOLOGICAL AMPLIFIER (September 18, 1989)
  • K894161 — ASC-950 ECG AMPLIFIER (August 3, 1989)
  • K874441 — BARD BIOPOTENTIAL AMPLIFIER (January 19, 1988)
  • K853652 — BERS-400A ELECTROPHYSIOLOGICAL AMPLIFIERS & INPUT (January 16, 1986)