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FDA 510(k)

EML 100

K-Number: K935120 · 1994-04-26

ApplicantRadiometer America, Inc.
Decision Date1994-04-26
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EML 100 is the device name listed in this FDA 510(k) record. The listed applicant is Radiometer America, Inc.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K935120. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EML 100?

EML 100 is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Radiometer America, Inc.. The 510(k) number is K935120.

When did EML 100 receive FDA 510(k) clearance?

EML 100 received FDA 510(k) clearance on 1994-04-26, under 510(k) number K935120.

Who is the listed applicant for EML 100?

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

What is the FDA product code for EML 100?

The FDA product code for EML 100 is JGS.

Other records listing Radiometer America, Inc. as applicant

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Related Devices (Code: JGS)

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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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