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FDA 510(k)

PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000

K-Number: K043287 · 2004-12-10

ApplicantMicromedical Devices, Inc.
Decision Date2004-12-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 is the device name listed in this FDA 510(k) record. The listed applicant is Micromedical Devices, Inc.. It received FDA 510(k) clearance on 2004-12-10 under 510(k) number K043287. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000?

PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 is a medical device that received FDA 510(k) clearance on 2004-12-10. The listed applicant is Micromedical Devices, Inc.. The 510(k) number is K043287.

When did PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 receive FDA 510(k) clearance?

PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 received FDA 510(k) clearance on 2004-12-10, under 510(k) number K043287.

Who is the listed applicant for PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000?

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

What is the FDA product code for PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000?

The FDA product code for PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 is IYO.

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Other records listing Micromedical Devices, Inc. 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.

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Related Devices (Code: IYO)

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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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