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SCHILLER ECG D-SUB2 B 3.1/2.55 x10 IEC

by Schiller Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K183425; other models may be affected

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613365003949 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2734-2024 FDA Class II initiated 24 Jul 2024 on shared 510(k) K183425

    Potential for high-frequency signal artifacts is recorded during an ECG acquisition performed by CARDIOVIT AT-180 electrocardiographs.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Schiller
Generic Name
Electrocardiographic lead set, reusable
Model / Ref / Catalog
ECG D-SUB2 B 3.1/2.55 x10 IEC, 2.400186
Primary DI / UDI-DI
07613365003949
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
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K183425)

Other devices from Schiller Corp.

See all devices from Schiller Corp. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No