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FDA 510(k)

MODEL 10200 PREMATURE INFANT INCUBATOR

K-Number: K862921 · 1987-04-01

ApplicantRotem Industries C/O Medsys, Inc.
Decision Date1987-04-01
Product CodeFMT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MODEL 10200 PREMATURE INFANT INCUBATOR is the device name listed in this FDA 510(k) record. The listed applicant is Rotem Industries C/O Medsys, Inc.. It received FDA 510(k) clearance on 1987-04-01 under 510(k) number K862921. The device is classified under product code FMT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 10200 PREMATURE INFANT INCUBATOR?

MODEL 10200 PREMATURE INFANT INCUBATOR is a medical device that received FDA 510(k) clearance on 1987-04-01. The listed applicant is Rotem Industries C/O Medsys, Inc.. The 510(k) number is K862921.

When did MODEL 10200 PREMATURE INFANT INCUBATOR receive FDA 510(k) clearance?

MODEL 10200 PREMATURE INFANT INCUBATOR received FDA 510(k) clearance on 1987-04-01, under 510(k) number K862921.

Who is the listed applicant for MODEL 10200 PREMATURE INFANT INCUBATOR?

The FDA 510(k) record lists Rotem Industries C/O Medsys, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 10200 PREMATURE INFANT INCUBATOR?

The FDA product code for MODEL 10200 PREMATURE INFANT INCUBATOR is FMT.

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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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