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Conmed FSA40-003R

by Conmed Corporation

Conmed FSA40-003R is a Class II device made by Conmed Corporation, cleared under FDA 510(k) K933649 on 18 Feb 1994 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 30653405022040), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K933649

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30653405022040 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK933649 Date18 Feb 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K933649 decided 18 Feb 1994 Active
  • FDA GUDID UDI-DI 30653405022040 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K933649
  2. Listed FDA GUDID 30653405022040

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Conmed
Generic name
Electrocardiographic lead set, reusable
Model / Ref / Catalog
FSA40-003R
Primary DI / UDI-DI
30653405022040
510(k) Number
FDA product code
DSA
GMDN term
Electrocardiographic lead set, reusable
Device class
Class II
Regulation number
870.2900
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electrocardiographic lead set, reusable

Cleared under the same submission (K933649)

and 7 more cleared under K933649

Similar devices in this category

Other devices filed under Electrocardiographic lead set, reusable.

Other devices from Conmed Corporation

See all devices from Conmed Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)