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 702 ECG/RESPIRATION/TEMPERATURE

K-Number: K884455 · 1989-03-09

Decision Date1989-03-09
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 702 ECG/RESPIRATION/TEMPERATURE is the device name listed in this FDA 510(k) record. The listed applicant is Ivy Biomedical Systems, Inc.. It received FDA 510(k) clearance on 1989-03-09 under 510(k) number K884455. 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 MODEL 702 ECG/RESPIRATION/TEMPERATURE?

MODEL 702 ECG/RESPIRATION/TEMPERATURE is a medical device that received FDA 510(k) clearance on 1989-03-09. The listed applicant is Ivy Biomedical Systems, Inc.. The 510(k) number is K884455.

When did MODEL 702 ECG/RESPIRATION/TEMPERATURE receive FDA 510(k) clearance?

MODEL 702 ECG/RESPIRATION/TEMPERATURE received FDA 510(k) clearance on 1989-03-09, under 510(k) number K884455.

Who is the listed applicant for MODEL 702 ECG/RESPIRATION/TEMPERATURE?

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

What is the FDA product code for MODEL 702 ECG/RESPIRATION/TEMPERATURE?

The FDA product code for MODEL 702 ECG/RESPIRATION/TEMPERATURE 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.

Other records listing Ivy Biomedical Systems, 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.

View all 27 devices →

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.

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.

↑