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)

PREAMPLIFIER MODEL 113

K-Number: K781289 · 1978-09-14

ApplicantPrinceton Applied Research Corp.
Decision Date1978-09-14
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PREAMPLIFIER MODEL 113 is the device name listed in this FDA 510(k) record. The listed applicant is Princeton Applied Research Corp.. It received FDA 510(k) clearance on 1978-09-14 under 510(k) number K781289. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PREAMPLIFIER MODEL 113?

PREAMPLIFIER MODEL 113 is a medical device that received FDA 510(k) clearance on 1978-09-14. The listed applicant is Princeton Applied Research Corp.. The 510(k) number is K781289.

When did PREAMPLIFIER MODEL 113 receive FDA 510(k) clearance?

PREAMPLIFIER MODEL 113 received FDA 510(k) clearance on 1978-09-14, under 510(k) number K781289.

Who is the listed applicant for PREAMPLIFIER MODEL 113?

The FDA 510(k) record lists Princeton Applied Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREAMPLIFIER MODEL 113?

The FDA product code for PREAMPLIFIER MODEL 113 is GWL.

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 Princeton Applied Research 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.

K781290SIGNAL AVERAGER MODEL 4202

Related Devices (Code: GWL)

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.

K243746Delphi AmplifierQuantalx NeroscienceK242832NExT Station; NExT Station AdvancedEb Neuro S.P.A.K240646DreamClearSomnomed Technologies Inc., Doing Business AS RemwareK242305BE Plus PRO, Neurotravel LIGHTEb Neuro S.P.A.K232210X-trodes System MX-TrodesK230148VlabDormotech Medical, Ltd.

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.

↑