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FDA 510(k)

MYELOTEC MYELOSCOPE

K-Number: K960194 · 1996-09-04

ApplicantMyelotec, Inc.
Decision Date1996-09-04
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MYELOTEC MYELOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Myelotec, Inc.. It received FDA 510(k) clearance on 1996-09-04 under 510(k) number K960194. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYELOTEC MYELOSCOPE?

MYELOTEC MYELOSCOPE is a medical device that received FDA 510(k) clearance on 1996-09-04. The listed applicant is Myelotec, Inc.. The 510(k) number is K960194.

When did MYELOTEC MYELOSCOPE receive FDA 510(k) clearance?

MYELOTEC MYELOSCOPE received FDA 510(k) clearance on 1996-09-04, under 510(k) number K960194.

Who is the listed applicant for MYELOTEC MYELOSCOPE?

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

What is the FDA product code for MYELOTEC MYELOSCOPE?

The FDA product code for MYELOTEC MYELOSCOPE is HRX.

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.

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Other records listing Myelotec, 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.

K980734MYELOTEC VIDEO GUIDED CATHETER

Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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