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FDA 510(k)

SCOLIMETER

K-Number: K831898 · 1983-07-19

ApplicantDr. Micheal A. Sabia
Decision Date1983-07-19
Product CodeKTZ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SCOLIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Dr. Micheal A. Sabia. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831898. The device is classified under product code KTZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOLIMETER?

SCOLIMETER is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Dr. Micheal A. Sabia. The 510(k) number is K831898.

When did SCOLIMETER receive FDA 510(k) clearance?

SCOLIMETER received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831898.

Who is the listed applicant for SCOLIMETER?

The FDA 510(k) record lists Dr. Micheal A. Sabia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SCOLIMETER?

The FDA product code for SCOLIMETER is KTZ.

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 Dr. Micheal A. Sabia 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.

K831899ENSWELL

Related Devices (Code: KTZ)

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.

K921266NK MEDICAL MICROMETER, MODEL MC001Nk Biotechnical Engineering Co.K841687SKYNDEX ELECTRONIC BODY FAT CALCULACaldwell, Justiss & Co., Inc.K820659A CALIPERTwin City Surgical, Inc.K810116ISOROBIC SKINFOLD CALIPERFitness Motivation Institute of AmericaK800363PARKE-DAVIS TOTAL KNEE PROSTHESISWarner-Lambert Co.K760521TAPE MEASUREMcgaw Laboratories

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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