FDA 510(k)

ROSYS MODELS 100 AND 200

K-Number: K913664 · 1991-08-30

Decision Date1991-08-30

Product CodeJQW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ROSYS MODELS 100 AND 200 is the device name listed in this FDA 510(k) record. The listed applicant is Packard Instrument Co., Inc.. It received FDA 510(k) clearance on 1991-08-30 under 510(k) number K913664. The device is classified under product code JQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROSYS MODELS 100 AND 200?

ROSYS MODELS 100 AND 200 is a medical device that received FDA 510(k) clearance on 1991-08-30. The listed applicant is Packard Instrument Co., Inc.. The 510(k) number is K913664.

When did ROSYS MODELS 100 AND 200 receive FDA 510(k) clearance?

ROSYS MODELS 100 AND 200 received FDA 510(k) clearance on 1991-08-30, under 510(k) number K913664.

Who is the listed applicant for ROSYS MODELS 100 AND 200?

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

What is the FDA product code for ROSYS MODELS 100 AND 200?

The FDA product code for ROSYS MODELS 100 AND 200 is JQW.

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Other records listing Packard Instrument Co., Inc. as applicant

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Related Devices (Code: JQW)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.