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)

VERSALAB APM

K-Number: K013281 · 2002-04-18

ApplicantNicolet Biomedical
Decision Date2002-04-18
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

VERSALAB APM is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical. It received FDA 510(k) clearance on 2002-04-18 under 510(k) number K013281. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERSALAB APM?

VERSALAB APM is a medical device that received FDA 510(k) clearance on 2002-04-18. The listed applicant is Nicolet Biomedical. The 510(k) number is K013281.

When did VERSALAB APM receive FDA 510(k) clearance?

VERSALAB APM received FDA 510(k) clearance on 2002-04-18, under 510(k) number K013281.

Who is the listed applicant for VERSALAB APM?

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

What is the FDA product code for VERSALAB APM?

The FDA product code for VERSALAB APM is HGM.

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 Nicolet Biomedical 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.

K020754NICOLET PIONEER TC8080K013419NICOLET ELECTROMAGNETIC NAVIGATION SYSTEMK011135GSI AUDERAK010521NICOLET VERSALABK002766NICOLET VASOGUARDK993939NICOLET EME LEGEND TC22

View all 8 devices →

Related Devices (Code: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, 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.

↑