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510(k) K851632

PCX-100 PATIENT INPUT LEADWIRE by Eaton Medical Group — Product Code DRW

K851632 is an FDA 510(k) premarket notification submitted by Eaton Medical Group for the device "PCX-100 PATIENT INPUT LEADWIRE". The FDA issued a decision of Substantially Equivalent on November 8, 1985. The device falls under product code DRW (Adaptor, Lead Switching, Electrocardiograph), a Class II device regulated under 21 CFR 870.2350. Eaton Medical Group has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1985
Date Received
April 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Lead Switching, Electrocardiograph
Device Class
Class II
Regulation Number
870.2350
Review Panel
CV
Submission Type

Other clearances by Eaton Medical Group

  • K851623 — MODEL TRC-40 TELEMETRY RECIEVER MODULE (January 22, 1986)
  • K851624 — MODEL TT-185 TELEMETRY TRANSMITTER (January 14, 1986)
  • K851625 — SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 (November 19, 1985)
  • K851627 — KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR (November 8, 1985)
  • K851631 — TMX-C1/C2 TRADMILL CONTROLLER ACCESS. (July 15, 1985)
  • K851629 — TMX-70 TREADMILL (July 9, 1985)
  • K851630 — TMX-80 TREADMILL (July 9, 1985)
  • K851628 — RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO (June 27, 1985)
  • K851633 — CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL (June 26, 1985)
  • K851626 — SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE (June 26, 1985)

Other clearances for product code DRW

  • K033513 — EASI ECG ALGORITHM (January 15, 2004)
  • K020456 — EASI 12 LEAD ALGORITHM (July 9, 2002)
  • K930786 — EPCOR (September 26, 1994)
  • K872781 — EASI LEAD SYSTEM CABLE ASSEMBLY (December 29, 1987)
  • K861981 — ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR (August 25, 1986)
  • K851627 — KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR (November 8, 1985)
  • K761210 — LIMB LEAD SEL. (ECG LEAD SWITCHING AD.) (December 21, 1976)

FDA data resources