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FDA 510(k)

PD CASTA-H

K-Number: K030632 · 2003-05-07

Decision Date2003-05-07
Product CodeEJH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PD CASTA-H is the device name listed in this FDA 510(k) record. The listed applicant is Mountain Medico, Inc.. It received FDA 510(k) clearance on 2003-05-07 under 510(k) number K030632. The device is classified under product code EJH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PD CASTA-H?

PD CASTA-H is a medical device that received FDA 510(k) clearance on 2003-05-07. The listed applicant is Mountain Medico, Inc.. The 510(k) number is K030632.

When did PD CASTA-H receive FDA 510(k) clearance?

PD CASTA-H received FDA 510(k) clearance on 2003-05-07, under 510(k) number K030632.

Who is the listed applicant for PD CASTA-H?

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

What is the FDA product code for PD CASTA-H?

The FDA product code for PD CASTA-H is EJH.

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.

Other records listing Mountain Medico, 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.

Related Devices (Code: EJH)

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.

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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