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FDA 510(k)

HEADLAMP HL2000.

K-Number: K994362 · 2000-05-11

ApplicantAngiolaz, Inc.
Decision Date2000-05-11
Product CodeFSR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HEADLAMP HL2000. is the device name listed in this FDA 510(k) record. The listed applicant is Angiolaz, Inc.. It received FDA 510(k) clearance on 2000-05-11 under 510(k) number K994362. The device is classified under product code FSR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEADLAMP HL2000.?

HEADLAMP HL2000. is a medical device that received FDA 510(k) clearance on 2000-05-11. The listed applicant is Angiolaz, Inc.. The 510(k) number is K994362.

When did HEADLAMP HL2000. receive FDA 510(k) clearance?

HEADLAMP HL2000. received FDA 510(k) clearance on 2000-05-11, under 510(k) number K994362.

Who is the listed applicant for HEADLAMP HL2000.?

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

What is the FDA product code for HEADLAMP HL2000.?

The FDA product code for HEADLAMP HL2000. is FSR.

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Other records listing Angiolaz, 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.

K99244750 W METAL HALIDE ILLUMINATOR, VES 0501.K982397VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEMK982409VES 1501-MK981819ANGIOLAZ VES-1CAMK981821VES 3001/2 DUAL OUTPUT VIDEO ILLUMINATORK981827VES 0281-M COMPLETE VIDEO ENDOSCOPIC VIDEO SYSTEM

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Related Devices (Code: FSR)

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.

K110528INTEGRA LED SURGICAL HEADLIGHT SYSTEMIntegra LifeSciences CorporationK031549SOLID STATE LAMP [LED] HEADLIGHTWelch Allyn, Inc.K031548LED HEADLIGHTWelch Allyn, 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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