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FDA 510(k)

BLY-501 ADAPTOR

K-Number: K012540 · 2001-09-26

ApplicantMicromedical Industries, Ltd.
Decision Date2001-09-26
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BLY-501 ADAPTOR is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical Industries, Ltd.. It received FDA 510(k) clearance on 2001-09-26 under 510(k) number K012540. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLY-501 ADAPTOR?

BLY-501 ADAPTOR is a medical device that received FDA 510(k) clearance on 2001-09-26. The listed applicant is Micromedical Industries, Ltd.. The 510(k) number is K012540.

When did BLY-501 ADAPTOR receive FDA 510(k) clearance?

BLY-501 ADAPTOR received FDA 510(k) clearance on 2001-09-26, under 510(k) number K012540.

Who is the listed applicant for BLY-501 ADAPTOR?

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

What is the FDA product code for BLY-501 ADAPTOR?

The FDA product code for BLY-501 ADAPTOR is DPS.

Related Clinical Trials

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Other records listing Micromedical Industries, 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.

K013311MODIFICATION TO: POCKETVIEW ECG SOFTWAREK990266MICROMEDICAL 12 LEAD SIMULTANEOUS CABLEK922528CMS SYSTEMK915624MODIFIED BIOLOGK915627PACEVIEW

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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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