FDA 510(k)

IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006

K-Number: K992057 · 1999-09-13

Decision Date1999-09-13

Product CodeBTM

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 is the device name listed in this FDA 510(k) record. The listed applicant is Sims Portex, Inc.. It received FDA 510(k) clearance on 1999-09-13 under 510(k) number K992057. 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 IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006?

IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 is a medical device that received FDA 510(k) clearance on 1999-09-13. The listed applicant is Sims Portex, Inc.. The 510(k) number is K992057.

When did IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 receive FDA 510(k) clearance?

IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 received FDA 510(k) clearance on 1999-09-13, under 510(k) number K992057.

Who is the listed applicant for IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006?

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

What is the FDA product code for IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006?

The FDA product code for IST RESPONSE MANUAL RESUSCITATOR, MODELS, 008000, 008003,008006 is BTM.

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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.