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FDA 510(k)

SARATOGA SCT HEATED HUMIDIFICATION SYSTEM

K-Number: K854363 · 1985-12-31

ApplicantSaratoga Medical Instrumentation, Inc.
Decision Date1985-12-31
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SARATOGA SCT HEATED HUMIDIFICATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Saratoga Medical Instrumentation, Inc.. It received FDA 510(k) clearance on 1985-12-31 under 510(k) number K854363. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SARATOGA SCT HEATED HUMIDIFICATION SYSTEM?

SARATOGA SCT HEATED HUMIDIFICATION SYSTEM is a medical device that received FDA 510(k) clearance on 1985-12-31. The listed applicant is Saratoga Medical Instrumentation, Inc.. The 510(k) number is K854363.

When did SARATOGA SCT HEATED HUMIDIFICATION SYSTEM receive FDA 510(k) clearance?

SARATOGA SCT HEATED HUMIDIFICATION SYSTEM received FDA 510(k) clearance on 1985-12-31, under 510(k) number K854363.

Who is the listed applicant for SARATOGA SCT HEATED HUMIDIFICATION SYSTEM?

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

What is the FDA product code for SARATOGA SCT HEATED HUMIDIFICATION SYSTEM?

The FDA product code for SARATOGA SCT HEATED HUMIDIFICATION SYSTEM is BTT.

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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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