FDA 510(k)

CALM

K-Number: K980719 · 1998-07-31

Decision Date1998-07-31

Product CodeHGM

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

CALM is the device name listed in this FDA 510(k) record. The listed applicant is Lms Medical Systems , Ltd.. It received FDA 510(k) clearance on 1998-07-31 under 510(k) number K980719. The device is classified under product code HGM. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALM?

CALM is a medical device that received FDA 510(k) clearance on 1998-07-31. The listed applicant is Lms Medical Systems , Ltd.. The 510(k) number is K980719.

When did CALM receive FDA 510(k) clearance?

CALM received FDA 510(k) clearance on 1998-07-31, under 510(k) number K980719.

Who is the listed applicant for CALM?

The FDA 510(k) record lists Lms Medical Systems , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALM?

The FDA product code for CALM is HGM.

Other records listing Lms Medical Systems , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K040788CALM PATTERNS, VERSION 01.00.00

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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.