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)

POLY G PHYSIOLOGICAL DATA RECORDER

K-Number: K897107 · 1990-03-12

ApplicantCns, Inc.
Decision Date1990-03-12
Product CodeBXO
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

POLY G PHYSIOLOGICAL DATA RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Cns, Inc.. It received FDA 510(k) clearance on 1990-03-12 under 510(k) number K897107. The device is classified under product code BXO. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLY G PHYSIOLOGICAL DATA RECORDER?

POLY G PHYSIOLOGICAL DATA RECORDER is a medical device that received FDA 510(k) clearance on 1990-03-12. The listed applicant is Cns, Inc.. The 510(k) number is K897107.

When did POLY G PHYSIOLOGICAL DATA RECORDER receive FDA 510(k) clearance?

POLY G PHYSIOLOGICAL DATA RECORDER received FDA 510(k) clearance on 1990-03-12, under 510(k) number K897107.

Who is the listed applicant for POLY G PHYSIOLOGICAL DATA RECORDER?

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

What is the FDA product code for POLY G PHYSIOLOGICAL DATA RECORDER?

The FDA product code for POLY G PHYSIOLOGICAL DATA RECORDER is BXO.

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 Cns, 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.

K955711BREATHE RIGHT NASAL STRIPK954914BREATHE RIGHT NASAL STRIPK953772BREATHE RIGHT NASAL STRIPK950273SLEEP TEST(TM)K921220BREATHE RIGHTK912436AM-PAK

View all 14 devices →

Related Devices (Code: BXO)

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.

K944027AG-839PA CO2 MODULE AND ACCESSORIESNihon Kohden America, 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.

↑