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FDA 510(k)

CALM PATTERNS, VERSION 01.00.00

K-Number: K040788 · 2005-02-08

ApplicantLms Medical Systems , Ltd.
Decision Date2005-02-08
Product CodeHGM
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CALM PATTERNS, VERSION 01.00.00 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 2005-02-08 under 510(k) number K040788. 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 PATTERNS, VERSION 01.00.00?

CALM PATTERNS, VERSION 01.00.00 is a medical device that received FDA 510(k) clearance on 2005-02-08. The listed applicant is Lms Medical Systems , Ltd.. The 510(k) number is K040788.

When did CALM PATTERNS, VERSION 01.00.00 receive FDA 510(k) clearance?

CALM PATTERNS, VERSION 01.00.00 received FDA 510(k) clearance on 2005-02-08, under 510(k) number K040788.

Who is the listed applicant for CALM PATTERNS, VERSION 01.00.00?

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 PATTERNS, VERSION 01.00.00?

The FDA product code for CALM PATTERNS, VERSION 01.00.00 is HGM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K980719CALM

Related Devices (Code: HGM)

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.

K254036Novii+ Wireless Patch SystemDatex Ohmeda, Inc.K253021ANNE MaternalSibel Health, Inc.K250777Sonicaid Team3Huntleigh Healthcare , Ltd.K241882Fetal & Maternal Monitor (F15A, F15A Air)Edan Instruments, Inc.K241368Sonicaid Team3Huntleigh Healthcare , Ltd.K241009PeriCALM Patterns 3.0Perigen, Inc.

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.

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