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)

SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME

K-Number: K903731 · 1991-02-04

ApplicantTeca, Inc.
Decision Date1991-02-04
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME is the device name listed in this FDA 510(k) record. The listed applicant is Teca, Inc.. It received FDA 510(k) clearance on 1991-02-04 under 510(k) number K903731. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME?

SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME is a medical device that received FDA 510(k) clearance on 1991-02-04. The listed applicant is Teca, Inc.. The 510(k) number is K903731.

When did SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME receive FDA 510(k) clearance?

SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME received FDA 510(k) clearance on 1991-02-04, under 510(k) number K903731.

Who is the listed applicant for SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME?

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

What is the FDA product code for SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME?

The FDA product code for SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME is GWF.

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 Teca, 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.

K962283EEG ELECTRODESK903004EE1114, 1118, 1121 ELECTRO-ENCEPHALOGRAPHK896666P460, DG32 ELECTROENCEPHALOGRAPHK894889TECA NEUROMAPPER 386K894088TECA NEUROMAPPER 1620, BRAIN MAPPERK890881TECA 1A96, 1A97 AND 1A98 ELECTROENCEPHALOGRAPHS

View all 29 devices →

Related Devices (Code: GWF)

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.

K263010ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpressinomed Medizintechnik GmbHK253301BraiN20® (BraiN20)Time IS Brain, S.L.K252842SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.K243982Nicolet EDXNatus Neurology IncorporatedK243495Natus Ultrapro S100 (982A0594)Natus Neurology IncorporatedK242345Delphi StimulatorQuantalx Neuroscience

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.

↑