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FDA 510(k)

INDISCAL DIGITAL MANOMETER

K-Number: K102192 · 2011-02-23

ApplicantBaylis Medical Co., Inc.
Decision Date2011-02-23
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

INDISCAL DIGITAL MANOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Co., Inc.. It received FDA 510(k) clearance on 2011-02-23 under 510(k) number K102192. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INDISCAL DIGITAL MANOMETER?

INDISCAL DIGITAL MANOMETER is a medical device that received FDA 510(k) clearance on 2011-02-23. The listed applicant is Baylis Medical Co., Inc.. The 510(k) number is K102192.

When did INDISCAL DIGITAL MANOMETER receive FDA 510(k) clearance?

INDISCAL DIGITAL MANOMETER received FDA 510(k) clearance on 2011-02-23, under 510(k) number K102192.

Who is the listed applicant for INDISCAL DIGITAL MANOMETER?

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

What is the FDA product code for INDISCAL DIGITAL MANOMETER?

The FDA product code for INDISCAL DIGITAL MANOMETER is FMF.

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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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