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)

IRAS PERIMETER

K-Number: K864012 · 1986-12-12

ApplicantRandwal Instrument Co., Inc.
Decision Date1986-12-12
Product CodeHPJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IRAS PERIMETER is the device name listed in this FDA 510(k) record. The listed applicant is Randwal Instrument Co., Inc.. It received FDA 510(k) clearance on 1986-12-12 under 510(k) number K864012. The device is classified under product code HPJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IRAS PERIMETER?

IRAS PERIMETER is a medical device that received FDA 510(k) clearance on 1986-12-12. The listed applicant is Randwal Instrument Co., Inc.. The 510(k) number is K864012.

When did IRAS PERIMETER receive FDA 510(k) clearance?

IRAS PERIMETER received FDA 510(k) clearance on 1986-12-12, under 510(k) number K864012.

Who is the listed applicant for IRAS PERIMETER?

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

What is the FDA product code for IRAS PERIMETER?

The FDA product code for IRAS PERIMETER is HPJ.

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 Randwal Instrument Co., 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.

K873990IRAS EDS INTERFEROMETRIC STIMULATORK873987IRAS GLARE TESTERK853556LASER IRASK842567PORTABLE ACUIOMETERK827577VARIABLE CONTRAST ACUIOMETER, DIAGNOSTIC LASER INTERFEROMETER

Related Devices (Code: HPJ)

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.

K853556LASER IRASRandwal Instrument Co., Inc.K822415THE OCUPLOT DCoherent Medical DivisionK813429LASER PHOTOCOAGULATOR ARGON MED. LASERAmerican Laser Corp.K781507RETINOMETERCoburn Optical Ind., 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.

↑