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FDA 510(k)

PATIENT HEATER SYSTEM, MODEL PH112

K-Number: K772015 · 1977-11-15

ApplicantCarolina Medical Electronics
Decision Date1977-11-15
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PATIENT HEATER SYSTEM, MODEL PH112 is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Medical Electronics. It received FDA 510(k) clearance on 1977-11-15 under 510(k) number K772015. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT HEATER SYSTEM, MODEL PH112?

PATIENT HEATER SYSTEM, MODEL PH112 is a medical device that received FDA 510(k) clearance on 1977-11-15. The listed applicant is Carolina Medical Electronics. The 510(k) number is K772015.

When did PATIENT HEATER SYSTEM, MODEL PH112 receive FDA 510(k) clearance?

PATIENT HEATER SYSTEM, MODEL PH112 received FDA 510(k) clearance on 1977-11-15, under 510(k) number K772015.

Who is the listed applicant for PATIENT HEATER SYSTEM, MODEL PH112?

The FDA 510(k) record lists Carolina Medical Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PATIENT HEATER SYSTEM, MODEL PH112?

The FDA product code for PATIENT HEATER SYSTEM, MODEL PH112 is DWJ.

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Other records listing Carolina Medical Electronics as applicant

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Related Devices (Code: DWJ)

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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.

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