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FDA 510(k)

LIGHTLINE-M

K-Number: K974240 · 1997-12-22

ApplicantWuestec Medical, Inc.
Decision Date1997-12-22
Product CodeIZX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LIGHTLINE-M is the device name listed in this FDA 510(k) record. The listed applicant is Wuestec Medical, Inc.. It received FDA 510(k) clearance on 1997-12-22 under 510(k) number K974240. The device is classified under product code IZX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGHTLINE-M?

LIGHTLINE-M is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Wuestec Medical, Inc.. The 510(k) number is K974240.

When did LIGHTLINE-M receive FDA 510(k) clearance?

LIGHTLINE-M received FDA 510(k) clearance on 1997-12-22, under 510(k) number K974240.

Who is the listed applicant for LIGHTLINE-M?

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

What is the FDA product code for LIGHTLINE-M?

The FDA product code for LIGHTLINE-M is IZX.

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Other records listing Wuestec Medical, 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.

K993962PENSIL TRAUMA, MODEL WWS6100K992603XRT 600 R/F, WRF 0600K992103C-QUESTK981880DX-480, ADD ON DIGITAL IMAGERK960083MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300K955414XRT 400

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Related Devices (Code: IZX)

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.

K110856RALCORalco S.R.L.K101036SHIMADZU COLLIMATOR R-20JShimadzu Corp.K042840SHIMADZU COLLIMATOR R-20JShimadzu Corp.K031771SHIMADZU COLLIMATOR R-30HShimadzu Corp.K981267FACTS MONOBLOCKDynarad Corp.K972966AXT 150M MANUAL COLLIMATOR (AXT 150M)Applied X-Ray Technologies, Inc.

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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