Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PINCH SENSOR, MODEL PF001

K-Number: K914055 · 1991-12-09

ApplicantNk Biotechnical Engineering Co.
Decision Date1991-12-09
Product CodeLBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PINCH SENSOR, MODEL PF001 is the device name listed in this FDA 510(k) record. The listed applicant is Nk Biotechnical Engineering Co.. It received FDA 510(k) clearance on 1991-12-09 under 510(k) number K914055. The device is classified under product code LBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PINCH SENSOR, MODEL PF001?

PINCH SENSOR, MODEL PF001 is a medical device that received FDA 510(k) clearance on 1991-12-09. The listed applicant is Nk Biotechnical Engineering Co.. The 510(k) number is K914055.

When did PINCH SENSOR, MODEL PF001 receive FDA 510(k) clearance?

PINCH SENSOR, MODEL PF001 received FDA 510(k) clearance on 1991-12-09, under 510(k) number K914055.

Who is the listed applicant for PINCH SENSOR, MODEL PF001?

The FDA 510(k) record lists Nk Biotechnical Engineering Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PINCH SENSOR, MODEL PF001?

The FDA product code for PINCH SENSOR, MODEL PF001 is LBB.

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 Nk Biotechnical Engineering Co. 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.

K934368NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001K923965NK GRASP SENSOR, MODEL GA002K923964NK GRASP SENSOR, MODEL GA001K923963NK DIGI-GRIP SENSOR, MODEL DGR001K921268NK DYNA-GRIP SENSOR, MODEL DG001K921266NK MEDICAL MICROMETER, MODEL MC001

View all 15 devices →

Related Devices (Code: LBB)

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.

K162412Hoggan Scientific® microFET2™Hoggan Scientific, LLCK073154FACTS HAND AND PINCH GRIP COMBOGlobal Services Group, LLCK052309DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006Saehan Corp.K042889DYNAMOMETER - MODEL FCE AND MODEL MSCAmetekK012492KADANCE 2000Kada Research, Inc.K981730DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002Nk Biotechnical Corp.

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.

↑