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FDA 510(k)

RSVP HALF SPHERE PHANTOM, MODEL DDP010

K-Number: K082909 · 2008-12-23

ApplicantThe Phantom Laboratory, Inc.
Decision Date2008-12-23
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RSVP HALF SPHERE PHANTOM, MODEL DDP010 is the device name listed in this FDA 510(k) record. The listed applicant is The Phantom Laboratory, Inc.. It received FDA 510(k) clearance on 2008-12-23 under 510(k) number K082909. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSVP HALF SPHERE PHANTOM, MODEL DDP010?

RSVP HALF SPHERE PHANTOM, MODEL DDP010 is a medical device that received FDA 510(k) clearance on 2008-12-23. The listed applicant is The Phantom Laboratory, Inc.. The 510(k) number is K082909.

When did RSVP HALF SPHERE PHANTOM, MODEL DDP010 receive FDA 510(k) clearance?

RSVP HALF SPHERE PHANTOM, MODEL DDP010 received FDA 510(k) clearance on 2008-12-23, under 510(k) number K082909.

Who is the listed applicant for RSVP HALF SPHERE PHANTOM, MODEL DDP010?

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

What is the FDA product code for RSVP HALF SPHERE PHANTOM, MODEL DDP010?

The FDA product code for RSVP HALF SPHERE PHANTOM, MODEL DDP010 is IYE.

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 The Phantom Laboratory, 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.

K081760RSVP PHANTOM PELVIS, MODEL TLP260K002840MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOMK954634RADIOSURGERY VERIFICATION PHANTOM

Related Devices (Code: IYE)

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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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