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FDA 510(k)

SPECTRASCAN

K-Number: K781103 · 1978-09-27

ApplicantMedishield, Inc.
Decision Date1978-09-27
Product CodeDAT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECTRASCAN is the device name listed in this FDA 510(k) record. The listed applicant is Medishield, Inc.. It received FDA 510(k) clearance on 1978-09-27 under 510(k) number K781103. The device is classified under product code DAT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPECTRASCAN?

SPECTRASCAN is a medical device that received FDA 510(k) clearance on 1978-09-27. The listed applicant is Medishield, Inc.. The 510(k) number is K781103.

When did SPECTRASCAN receive FDA 510(k) clearance?

SPECTRASCAN received FDA 510(k) clearance on 1978-09-27, under 510(k) number K781103.

Who is the listed applicant for SPECTRASCAN?

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

What is the FDA product code for SPECTRASCAN?

The FDA product code for SPECTRASCAN is DAT.

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Other records listing Medishield, 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.

K780645HMD-2000 BATTERY-POWERED MINI-DRILL, THEK780646AIR-PWOERED COLDRILLK780202MONOMER EVACUATION SYSTEMK770161MICROFENESTRATED HIP REPLACEMENT COMPON.K761021ANKLE INSTRUMENTS (FREEMAN-SWANSON)K761020ANKLE (FREEMAN-SWANSON)

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Related Devices (Code: DAT)

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.

K924892FIBRINOSTIKA(R) FGDP MICROELISA SYSTEMOrganon Teknika Corp.

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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