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FDA 510(k)

Infant Transport Mattress Warmer with Disc

K-Number: K163295 · 2017-07-24

ApplicantRapid Aid Corp.
Decision Date2017-07-24
Product CodeIMD
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Infant Transport Mattress Warmer with Disc is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Aid Corp.. It received FDA 510(k) clearance on 2017-07-24 under 510(k) number K163295. The device is classified under product code IMD. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Infant Transport Mattress Warmer with Disc?

Infant Transport Mattress Warmer with Disc is a medical device that received FDA 510(k) clearance on 2017-07-24. The listed applicant is Rapid Aid Corp.. The 510(k) number is K163295.

When did Infant Transport Mattress Warmer with Disc receive FDA 510(k) clearance?

Infant Transport Mattress Warmer with Disc received FDA 510(k) clearance on 2017-07-24, under 510(k) number K163295.

Who is the listed applicant for Infant Transport Mattress Warmer with Disc?

The FDA 510(k) record lists Rapid Aid Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infant Transport Mattress Warmer with Disc?

The FDA product code for Infant Transport Mattress Warmer with Disc is IMD.

Related Devices (Code: IMD)

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.

K221653InfaTherm Disposable Infant Warming MattressInternational Biomedical

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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