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)

SURGIC-ALERT MONITOR

K-Number: K930514 · 1993-08-19

ApplicantNovatec Medical Products, Inc.--Glove Monitor
Decision Date1993-08-19
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SURGIC-ALERT MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Novatec Medical Products, Inc.--Glove Monitor. It received FDA 510(k) clearance on 1993-08-19 under 510(k) number K930514. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGIC-ALERT MONITOR?

SURGIC-ALERT MONITOR is a medical device that received FDA 510(k) clearance on 1993-08-19. The listed applicant is Novatec Medical Products, Inc.--Glove Monitor. The 510(k) number is K930514.

When did SURGIC-ALERT MONITOR receive FDA 510(k) clearance?

SURGIC-ALERT MONITOR received FDA 510(k) clearance on 1993-08-19, under 510(k) number K930514.

Who is the listed applicant for SURGIC-ALERT MONITOR?

The FDA 510(k) record lists Novatec Medical Products, Inc.--Glove Monitor as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGIC-ALERT MONITOR?

The FDA product code for SURGIC-ALERT MONITOR is LDQ.

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: LDQ)

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.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K981032PIV SYSTEMMedical Solutions, Inc.K973747CONTROLLED TEMPERATURE CABINET SYSTEMSmithK955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & 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.

↑