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FDA 510(k)

PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE

K-Number: K001852 · 2001-02-21

ApplicantItamar Medical (C.M.) 1997 , Ltd.
Decision Date2001-02-21
Product CodeDQK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Itamar Medical (C.M.) 1997 , Ltd.. It received FDA 510(k) clearance on 2001-02-21 under 510(k) number K001852. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE?

PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE is a medical device that received FDA 510(k) clearance on 2001-02-21. The listed applicant is Itamar Medical (C.M.) 1997 , Ltd.. The 510(k) number is K001852.

When did PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE receive FDA 510(k) clearance?

PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE received FDA 510(k) clearance on 2001-02-21, under 510(k) number K001852.

Who is the listed applicant for PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE?

The FDA 510(k) record lists Itamar Medical (C.M.) 1997 , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE?

The FDA product code for PERIPHERAL ARTERIAL TONOMETER-PAT 1000RD DEVICE is DQK.

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Other records listing Itamar Medical (C.M.) 1997 , 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.

K010156SLEEP PAT 200 DEVICEK010739WATCH-PAT 100

Related Devices (Code: DQK)

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.

K261729EnSite™ X EP SystemAbbott MedicalK262005Affera Integrated Mapping SystemMedtronic, Inc.K253692AVVIGO™+ Multi-Modality Guidance SystemBoston ScientificK253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott MedicalK252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC

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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