Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STETH-SHIELD(TM)

K-Number: K892890 · 1989-12-01

ApplicantNorth East Technology
Decision Date1989-12-01
Product CodeDQD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

STETH-SHIELD(TM) is the device name listed in this FDA 510(k) record. The listed applicant is North East Technology. It received FDA 510(k) clearance on 1989-12-01 under 510(k) number K892890. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STETH-SHIELD(TM)?

STETH-SHIELD(TM) is a medical device that received FDA 510(k) clearance on 1989-12-01. The listed applicant is North East Technology. The 510(k) number is K892890.

When did STETH-SHIELD(TM) receive FDA 510(k) clearance?

STETH-SHIELD(TM) received FDA 510(k) clearance on 1989-12-01, under 510(k) number K892890.

Who is the listed applicant for STETH-SHIELD(TM)?

The FDA 510(k) record lists North East Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STETH-SHIELD(TM)?

The FDA product code for STETH-SHIELD(TM) is DQD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing North East Technology as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K892892NET STRETCHER PAD (TM)

Related Devices (Code: DQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261494Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart Wireless Stethoscope (STEMO720);Smart Wireless Stethoscope (STEMO730)Shanghai Hulu Devices Co., Ltd.K261694CORE 300 Digital StethoscopeEko Health, Inc.K252915AiSteth®Ai Health Highway India Pvt., Ltd.K252089Tyto Stethoscope (G3)Tyto Care , Ltd.K252076Kneevoice Cartilage Evaluation System (750-3600-001)Kneevoice, Inc.K252284eMurmur Heart AICsd Labs

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑