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FDA 510(k)

PS 3000 DIGATAL PHOTOSPOT SYSTEM

K-Number: K030061 · 2003-04-07

ApplicantPrecise Optics
Decision Date2003-04-07
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PS 3000 DIGATAL PHOTOSPOT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Precise Optics. It received FDA 510(k) clearance on 2003-04-07 under 510(k) number K030061. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PS 3000 DIGATAL PHOTOSPOT SYSTEM?

PS 3000 DIGATAL PHOTOSPOT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-04-07. The listed applicant is Precise Optics. The 510(k) number is K030061.

When did PS 3000 DIGATAL PHOTOSPOT SYSTEM receive FDA 510(k) clearance?

PS 3000 DIGATAL PHOTOSPOT SYSTEM received FDA 510(k) clearance on 2003-04-07, under 510(k) number K030061.

Who is the listed applicant for PS 3000 DIGATAL PHOTOSPOT SYSTEM?

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 PS 3000 DIGATAL PHOTOSPOT SYSTEM?

The FDA product code for PS 3000 DIGATAL PHOTOSPOT SYSTEM is OWB.

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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.

K935580PHF20 20 MOBILE C-ARM IMAGE INTENSIFIERK932878PRECISION INTRA-ORAL SCOPESK914084ENDOSCOPESK914184P2020-8-0 BEAM-LIMITING DEVICEK911744PRECISION OPTICS CORPORATION LAPAROSCOPEK903459PRECISION OPTICS ENDOSCOPE ADAPTER

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Related Devices (Code: OWB)

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.

K253726uAngio AVIVA CXShanghai United Imaging Healthcare Co., Ltd.K261413EXTRON 3;EXTRON 6DRTECH CorporationK254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, 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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