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)

MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM

K-Number: K882609 · 1989-01-19

ApplicantWaltham Div. Hewlett Packard
Decision Date1989-01-19
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Waltham Div. Hewlett Packard. It received FDA 510(k) clearance on 1989-01-19 under 510(k) number K882609. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM?

MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 1989-01-19. The listed applicant is Waltham Div. Hewlett Packard. The 510(k) number is K882609.

When did MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM receive FDA 510(k) clearance?

MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM received FDA 510(k) clearance on 1989-01-19, under 510(k) number K882609.

Who is the listed applicant for MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM?

The FDA 510(k) record lists Waltham Div. Hewlett Packard as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM?

The FDA product code for MODELS M1175A & M1176A COMPONENT MONITORING SYSTEM is DRT.

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: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, 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.

↑