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)

HEINE LAMBDA 100

K-Number: K944156 · 1995-01-12

ApplicantHeine USA , Ltd.
Decision Date1995-01-12
Product CodeHOX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HEINE LAMBDA 100 is the device name listed in this FDA 510(k) record. The listed applicant is Heine USA , Ltd.. It received FDA 510(k) clearance on 1995-01-12 under 510(k) number K944156. The device is classified under product code HOX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEINE LAMBDA 100?

HEINE LAMBDA 100 is a medical device that received FDA 510(k) clearance on 1995-01-12. The listed applicant is Heine USA , Ltd.. The 510(k) number is K944156.

When did HEINE LAMBDA 100 receive FDA 510(k) clearance?

HEINE LAMBDA 100 received FDA 510(k) clearance on 1995-01-12, under 510(k) number K944156.

Who is the listed applicant for HEINE LAMBDA 100?

The FDA 510(k) record lists Heine USA , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEINE LAMBDA 100?

The FDA product code for HEINE LAMBDA 100 is HOX.

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

Related Devices (Code: HOX)

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.

K100095CENTRAL VISION ANALYZER MODEL 1000Vimetrics,Llc.K881971OCCU-TECH VISION TESTApplied Vision Concepts, Inc.K883337PL 20/20 INFANT VISION TESTEROptimed Technologies, Inc.K882634VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLAREVistech Consultants, Inc.K881358PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAMNeuroscientific Corp.K881059MCT 8000 (MULTI-VISION CONTRAST TESTER)Vistech Consultants, Inc.

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.

↑