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FDA 510(k)

SIMPLIFY COMPACT RESUSCITATOR

K-Number: K021716 · 2002-10-08

ApplicantPolymed (Xiamen) Plastic Industrial Co., Ltd.
Decision Date2002-10-08
Product CodeBTM
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SIMPLIFY COMPACT RESUSCITATOR is the device name listed in this FDA 510(k) record. The listed applicant is Polymed (Xiamen) Plastic Industrial Co., Ltd.. It received FDA 510(k) clearance on 2002-10-08 under 510(k) number K021716. The device is classified under product code BTM. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLIFY COMPACT RESUSCITATOR?

SIMPLIFY COMPACT RESUSCITATOR is a medical device that received FDA 510(k) clearance on 2002-10-08. The listed applicant is Polymed (Xiamen) Plastic Industrial Co., Ltd.. The 510(k) number is K021716.

When did SIMPLIFY COMPACT RESUSCITATOR receive FDA 510(k) clearance?

SIMPLIFY COMPACT RESUSCITATOR received FDA 510(k) clearance on 2002-10-08, under 510(k) number K021716.

Who is the listed applicant for SIMPLIFY COMPACT RESUSCITATOR?

The FDA 510(k) record lists Polymed (Xiamen) Plastic Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPLIFY COMPACT RESUSCITATOR?

The FDA product code for SIMPLIFY COMPACT RESUSCITATOR is BTM.

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Related Devices (Code: BTM)

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

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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