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510(k) K802282

ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON by Consolidated Medical Equipment, Inc. — Product Code DRR

K802282 is an FDA 510(k) premarket notification submitted by Consolidated Medical Equipment, Inc. for the device "ESOPHAGEAL ECG PREAMPLIFIER & SIGNAL CON". The FDA issued a decision of Substantially Equivalent on October 10, 1980. The device falls under product code DRR (Amplifier And Signal Conditioner, Biopotential), a Class II device regulated under 21 CFR 870.2050. Consolidated Medical Equipment, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1980
Date Received
September 19, 1980
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 Consolidated Medical Equipment, Inc.

  • K854040 — I.V. DRESSING (January 9, 1986)
  • K850130 — PRN ECG ELECTRODE (April 9, 1985)
  • K850132 — DISPOSABLE CONDUCTIVE ADHESIVE DIAGNOSTIC ECG ELEC (April 9, 1985)
  • K850037 — CLOSED WOUND DRAIN (March 19, 1985)
  • K844942 — PLURA-GARD CHEST DRAINAGE SYSTEM (March 12, 1985)
  • K850311 — DISPOS. CONDUCTIVE ADHESIVE TENS PAD (March 5, 1985)
  • K850131 — CONDUCTIVE ADHESIVE POST-OP ELECTRODE-TENS (March 5, 1985)
  • K850133 — VENI-GARD AP & TPN, DERMA-SHIELD, DERMA-SHIELD JR. (February 28, 1985)
  • K850129 — MODIFIED CONDUCTIVE ADHESIVE ELECTROSURGICAL GROUN (February 28, 1985)
  • K844372 — HAND CONTROLLED ELECTROSURGICAL PENCIL DISPOSABLE (February 21, 1985)

Other clearances for product code DRR

  • K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 (December 19, 2002)
  • K971570 — EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 (December 29, 1997)
  • K925346 — EP AMP, MODEL #901 (April 30, 1993)
  • K914381 — HORIZON 9000/HIS OPTION AMPLIFIER (January 28, 1992)
  • K911935 — CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED (July 22, 1991)
  • 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)

FDA data resources