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)

GRASS BRAINWAVE SOFTWARE

K-Number: K970951 · 1997-05-19

ApplicantAstro-Med, Inc.
Decision Date1997-05-19
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

GRASS BRAINWAVE SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Astro-Med, Inc.. It received FDA 510(k) clearance on 1997-05-19 under 510(k) number K970951. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GRASS BRAINWAVE SOFTWARE?

GRASS BRAINWAVE SOFTWARE is a medical device that received FDA 510(k) clearance on 1997-05-19. The listed applicant is Astro-Med, Inc.. The 510(k) number is K970951.

When did GRASS BRAINWAVE SOFTWARE receive FDA 510(k) clearance?

GRASS BRAINWAVE SOFTWARE received FDA 510(k) clearance on 1997-05-19, under 510(k) number K970951.

Who is the listed applicant for GRASS BRAINWAVE SOFTWARE?

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

What is the FDA product code for GRASS BRAINWAVE SOFTWARE?

The FDA product code for GRASS BRAINWAVE SOFTWARE is OLV.

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 Astro-Med, 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.

K081551TWIN NEUROTRAC-IIIK050425AURA-PSGK033978ADAMK963669GRASS MODEL 15 NEURODATA AMPLIFIER SYSTEMK934644K3 SYSTEMK912929DASH IV

View all 13 devices →

Related Devices (Code: OLV)

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.

K261747Report StudioBeacon Biosignals, Inc.K260585Noxturnal WebNox Medical EhfK242447Falcon HSTCompumedics LimitedK241288Noxturnal WebNox Medical EhfK240700HomeSleepTest (HST, HST REM+)Somnomedics GmbHK213007Cerebra Sleep SystemCerebra 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.

↑