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)

5011 GANZFELD STIMULATOR

K-Number: K822922 · 1982-12-28

ApplicantLife-Tech Intl., Inc.
Decision Date1982-12-28
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

5011 GANZFELD STIMULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Life-Tech Intl., Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K822922. The device is classified under product code HLX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5011 GANZFELD STIMULATOR?

5011 GANZFELD STIMULATOR is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is Life-Tech Intl., Inc.. The 510(k) number is K822922.

When did 5011 GANZFELD STIMULATOR receive FDA 510(k) clearance?

5011 GANZFELD STIMULATOR received FDA 510(k) clearance on 1982-12-28, under 510(k) number K822922.

Who is the listed applicant for 5011 GANZFELD STIMULATOR?

The FDA 510(k) record lists Life-Tech Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 5011 GANZFELD STIMULATOR?

The FDA product code for 5011 GANZFELD STIMULATOR is HLX.

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 Life-Tech Intl., Inc. 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.

K001129PROLONG, MODELS PL50, PL100, PL150K954505EZ STIMK955031MAXISTIMK954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERK954341URODYNAMICS TUBING AND INFUSION SETSK953451UROPUMP TUBE & DAMPING CHAMGER

View all 68 devices →

Related Devices (Code: HLX)

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.

K003442MODIFICATION TO EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K983983EDI VERIS SYSTEMElectro-Diagnostic Imaging, Inc.K925741CLARUS ENDOSCOPIC HOOK KNIFEClarus Medical Systems, Inc.K914393RETINA TESTERRetina TesterK914163SCOPTOPIC SENSITIVITY TEST-1[SST-1]Lkc Technologies, Inc.K873990IRAS EDS INTERFEROMETRIC STIMULATORRandwal Instrument Co., 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.

↑