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FDA 510(k)

CAIRD TECHNOLOGY HOLTER 2000

K-Number: K012686 · 2001-12-13

ApplicantCaird Technology
Decision Date2001-12-13
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CAIRD TECHNOLOGY HOLTER 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Caird Technology. It received FDA 510(k) clearance on 2001-12-13 under 510(k) number K012686. 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 CAIRD TECHNOLOGY HOLTER 2000?

CAIRD TECHNOLOGY HOLTER 2000 is a medical device that received FDA 510(k) clearance on 2001-12-13. The listed applicant is Caird Technology. The 510(k) number is K012686.

When did CAIRD TECHNOLOGY HOLTER 2000 receive FDA 510(k) clearance?

CAIRD TECHNOLOGY HOLTER 2000 received FDA 510(k) clearance on 2001-12-13, under 510(k) number K012686.

Who is the listed applicant for CAIRD TECHNOLOGY HOLTER 2000?

The FDA 510(k) record lists Caird Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAIRD TECHNOLOGY HOLTER 2000?

The FDA product code for CAIRD TECHNOLOGY HOLTER 2000 is DPS.

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.

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Other records listing Caird Technology 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.

K101016ANS SYSTEMK971336CAIRD TECHNOLOGY SPIROMETER

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

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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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