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FDA 510(k)

UNIVERSAL PACK

K-Number: K834155 · 1984-06-19

ApplicantAtlantic Optical Systems, Inc.
Decision Date1984-06-19
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Optical Systems, Inc.. It received FDA 510(k) clearance on 1984-06-19 under 510(k) number K834155. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNIVERSAL PACK?

UNIVERSAL PACK is a medical device that received FDA 510(k) clearance on 1984-06-19. The listed applicant is Atlantic Optical Systems, Inc.. The 510(k) number is K834155.

When did UNIVERSAL PACK receive FDA 510(k) clearance?

UNIVERSAL PACK received FDA 510(k) clearance on 1984-06-19, under 510(k) number K834155.

Who is the listed applicant for UNIVERSAL PACK?

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

What is the FDA product code for UNIVERSAL PACK?

The FDA product code for UNIVERSAL PACK is HQE.

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 Atlantic Optical Systems, 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.

K850532ATLANTIC OPTICAL SYSTEMS, INC. UNIVERSAL PACKK850533ATLANTIC OPTICAL SYSTEMS OPTIFILTER SYSTEMK831701UNIVERSAL PACK

Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, 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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