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FDA 510(k)

HA-2000 REAL EAR SPECTROSCOPE

K-Number: K862026 · 1986-08-15

ApplicantAnd/Or Corp.
Decision Date1986-08-15
Product CodeETW
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HA-2000 REAL EAR SPECTROSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is And/Or Corp.. It received FDA 510(k) clearance on 1986-08-15 under 510(k) number K862026. The device is classified under product code ETW. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HA-2000 REAL EAR SPECTROSCOPE?

HA-2000 REAL EAR SPECTROSCOPE is a medical device that received FDA 510(k) clearance on 1986-08-15. The listed applicant is And/Or Corp.. The 510(k) number is K862026.

When did HA-2000 REAL EAR SPECTROSCOPE receive FDA 510(k) clearance?

HA-2000 REAL EAR SPECTROSCOPE received FDA 510(k) clearance on 1986-08-15, under 510(k) number K862026.

Who is the listed applicant for HA-2000 REAL EAR SPECTROSCOPE?

The FDA 510(k) record lists And/Or Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HA-2000 REAL EAR SPECTROSCOPE?

The FDA product code for HA-2000 REAL EAR SPECTROSCOPE is ETW.

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 And/Or Corp. 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.

K851143RHINOMANOMETERS NR3, NR4

Related Devices (Code: ETW)

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.

K122028AURICAL HITGn OtometricsK113831PRIMUS HEARING INSTRUMENT TEST UNITAuditdata A/SK110286GN OTOMETRICS TYPE 1053 FREEFITGn Otometrics A/SK093006FONIX ,MODEL 8000Frye Electronics, Inc.K071462UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2)Siemens Hearing Instruments, Inc.K061104SPEECHLINK 100 TYPE 1053Gn Otometrics A/S

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.

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