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FDA 510(k)

OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)

K-Number: K963333 · 1996-10-22

ApplicantKarl Storz Imaging, Inc.
Decision Date1996-10-22
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Imaging, Inc.. It received FDA 510(k) clearance on 1996-10-22 under 510(k) number K963333. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)?

OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) is a medical device that received FDA 510(k) clearance on 1996-10-22. The listed applicant is Karl Storz Imaging, Inc.. The 510(k) number is K963333.

When did OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) receive FDA 510(k) clearance?

OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) received FDA 510(k) clearance on 1996-10-22, under 510(k) number K963333.

Who is the listed applicant for OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)?

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

What is the FDA product code for OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)?

The FDA product code for OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) is HKI.

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Other records listing Karl Storz Imaging, 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.

K003325KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEMK001362KARL STORZ 3D VIDEO SYSTEMK994090KARL STORZ AUTOCLAVABLE CAMERA HEADK990154KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEMK974391KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEMK973252KARL STORZ DIRECT COUPLED CAMERA HEAD

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Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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