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FDA 510(k)

MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM

K-Number: K002840 · 2000-11-17

ApplicantThe Phantom Laboratory, Inc.
Decision Date2000-11-17
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM 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 2000-11-17 under 510(k) number K002840. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM?

MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM is a medical device that received FDA 510(k) clearance on 2000-11-17. The listed applicant is The Phantom Laboratory, Inc.. The 510(k) number is K002840.

When did MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM receive FDA 510(k) clearance?

MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM received FDA 510(k) clearance on 2000-11-17, under 510(k) number K002840.

Who is the listed applicant for MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM?

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 MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM?

The FDA product code for MARKS REFERENCE PHANTOM, MEASURE REFERENCE PHANTOM is IZI.

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Other records listing The Phantom Laboratory, Inc. as applicant

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K082909RSVP HALF SPHERE PHANTOM, MODEL DDP010K081760RSVP PHANTOM PELVIS, MODEL TLP260K954634RADIOSURGERY VERIFICATION PHANTOM

Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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