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FDA 510(k)

P2020-8-0 BEAM-LIMITING DEVICE

K-Number: K914184 · 1991-11-27

ApplicantPrecise Optics
Decision Date1991-11-27
Product CodeKPW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

P2020-8-0 BEAM-LIMITING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Precise Optics. It received FDA 510(k) clearance on 1991-11-27 under 510(k) number K914184. The device is classified under product code KPW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the P2020-8-0 BEAM-LIMITING DEVICE?

P2020-8-0 BEAM-LIMITING DEVICE is a medical device that received FDA 510(k) clearance on 1991-11-27. The listed applicant is Precise Optics. The 510(k) number is K914184.

When did P2020-8-0 BEAM-LIMITING DEVICE receive FDA 510(k) clearance?

P2020-8-0 BEAM-LIMITING DEVICE received FDA 510(k) clearance on 1991-11-27, under 510(k) number K914184.

Who is the listed applicant for P2020-8-0 BEAM-LIMITING DEVICE?

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

What is the FDA product code for P2020-8-0 BEAM-LIMITING DEVICE?

The FDA product code for P2020-8-0 BEAM-LIMITING DEVICE is KPW.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Precise Optics 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.

K030061PS 3000 DIGATAL PHOTOSPOT SYSTEMK935580PHF20 20 MOBILE C-ARM IMAGE INTENSIFIERK932878PRECISION INTRA-ORAL SCOPESK914084ENDOSCOPESK911744PRECISION OPTICS CORPORATION LAPAROSCOPEK903459PRECISION OPTICS ENDOSCOPE ADAPTER

View all 13 devices →

Related Devices (Code: KPW)

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.

K093596LUMOS, MODEL R 72BLumos, Inc.K062788COLLIMATOR, MODEL M-38Umi InternationalK030487R 72Ralco S.R.L.K954310BLA-800AToshiba Medical SystemsK946320R 302Ralco S.R.L.K904587DENSICOMP 250L. Keroack Co.

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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