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)

MODEL 1700, HYDRO PREP

K-Number: K970694 · 1997-05-14

ApplicantPhysiometrix, Inc.
Decision Date1997-05-14
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODEL 1700, HYDRO PREP is the device name listed in this FDA 510(k) record. The listed applicant is Physiometrix, Inc.. It received FDA 510(k) clearance on 1997-05-14 under 510(k) number K970694. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 1700, HYDRO PREP?

MODEL 1700, HYDRO PREP is a medical device that received FDA 510(k) clearance on 1997-05-14. The listed applicant is Physiometrix, Inc.. The 510(k) number is K970694.

When did MODEL 1700, HYDRO PREP receive FDA 510(k) clearance?

MODEL 1700, HYDRO PREP received FDA 510(k) clearance on 1997-05-14, under 510(k) number K970694.

Who is the listed applicant for MODEL 1700, HYDRO PREP?

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

What is the FDA product code for MODEL 1700, HYDRO PREP?

The FDA product code for MODEL 1700, HYDRO PREP is GYB.

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 Physiometrix, 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.

K051874SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SETK033999SEDLINE WITH FRONTAL PSIK020670MODEL 4310 PSARRAY2 EEG ELECTRODEK020671PSA4000 EEG MONITOR WITH FRONTAL PSIK001069MODEL 4000 EEG MONITOR WITH PSI (PSA4000)K001055MODEL 4300 PSARRAY EEG ELECTRODE SET

View all 22 devices →

Related Devices (Code: GYB)

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.

K243749Jmoon Conductive GelShenzhen Ulike Smart Electronics Co., Ltd.K220735Avologi Gel Primer (Model: Av25)Premier North America, Inc.K222770Conductive GelTop-Rank Health Care Co., Ltd.K221724Conductive GelTone-A-Matic International, Inc.K212325EEG-acpSomnomedics GmbHK212326AC Cream - Conductive pasteSpes Medica Srl

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.

↑