STETH-SHIELD(TM)— 510(k) K892890

Substantially Equivalent

North East Technology

FDA 510(k) clearance K892890 for STETH-SHIELD(TM), Substantially Equivalent on 1989-12-01. Applicant: North East Technology. Device class: 2.

Clearance details

Applicant: North East Technology
Product code: Code DQD
Device class: Class 2
Regulation: 21 CFR 870.1875
Advisory panel: Cardiovascular
Date received: 1989-04-20
Decision date: 1989-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva On The Lake, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQD

K261494 — Smart Wireless Stethoscope (4 models)2026-07-31
K261694 — CORE 300 Digital Stethoscope2026-07-23
K252915 — AiSteth®2026-05-22
K252089 — Tyto Stethoscope (G3)2026-03-12
K252076 — Kneevoice Cartilage Evaluation System (750-3600-001)2026-02-06

More clearances from North East Technology

K892892 — NET STRETCHER PAD (TM)1989-11-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.