Home / 510(k) Clearances / K861981

510(k) K861981

ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR by Vital Signs, Inc. — Product Code DRW

K861981 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "ELECTROCARDIOGRAPH LEAD SWITCHING ADAPTOR". The FDA issued a decision of Substantially Equivalent on August 25, 1986. The device falls under product code DRW (Adaptor, Lead Switching, Electrocardiograph), a Class II device regulated under 21 CFR 870.2350. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1986
Date Received
May 22, 1986
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 Vital Signs, Inc.

  • K112902 — ENFLOW IV FLUID WARMER (March 14, 2012)
  • K041309 — IMASK TM (June 30, 2004)
  • K030985 — BREAS PV 10I CPAP SYSTEM, MODEL PV 10I (October 15, 2003)
  • K022402 — DISPOSABLE PRESSURE MANOMETER (August 22, 2002)
  • K021315 — SURE-LOK (August 21, 2002)
  • K002454 — BREAS HA50 HUMIDIFIER, MODEL HA50 (March 7, 2001)
  • K001553 — BREAS PV 100 CPAP SYSTEM (August 3, 2000)
  • K000441 — BODYGUARD (April 11, 2000)
  • K994044 — CLEEN-ABLE (February 25, 2000)
  • K990412 — CUFF-ABLE PLUS (September 1, 1999)

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)
  • K851632 — PCX-100 PATIENT INPUT LEADWIRE (November 8, 1985)
  • 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