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FDA 510(k)

CT-1600 DIGITAL PULSE RATE MONITOR

K-Number: K802204 · 1980-10-03

ApplicantIndustrial & Biomedical Sensors Corp.
Decision Date1980-10-03
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CT-1600 DIGITAL PULSE RATE MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Industrial & Biomedical Sensors Corp.. It received FDA 510(k) clearance on 1980-10-03 under 510(k) number K802204. 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 CT-1600 DIGITAL PULSE RATE MONITOR?

CT-1600 DIGITAL PULSE RATE MONITOR is a medical device that received FDA 510(k) clearance on 1980-10-03. The listed applicant is Industrial & Biomedical Sensors Corp.. The 510(k) number is K802204.

When did CT-1600 DIGITAL PULSE RATE MONITOR receive FDA 510(k) clearance?

CT-1600 DIGITAL PULSE RATE MONITOR received FDA 510(k) clearance on 1980-10-03, under 510(k) number K802204.

Who is the listed applicant for CT-1600 DIGITAL PULSE RATE MONITOR?

The FDA 510(k) record lists Industrial & Biomedical Sensors Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CT-1600 DIGITAL PULSE RATE MONITOR?

The FDA product code for CT-1600 DIGITAL PULSE RATE MONITOR is DRT.

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Other records listing Industrial & Biomedical Sensors Corp. as applicant

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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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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