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)

ROCCOBAROCCO & PRO-DYNAMIX

K-Number: K965170 · 1997-03-11

ApplicantMichelangelo, Inc.
Decision Date1997-03-11
Product CodeHQY
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ROCCOBAROCCO & PRO-DYNAMIX is the device name listed in this FDA 510(k) record. The listed applicant is Michelangelo, Inc.. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K965170. The device is classified under product code HQY. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCCOBAROCCO & PRO-DYNAMIX?

ROCCOBAROCCO & PRO-DYNAMIX is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is Michelangelo, Inc.. The 510(k) number is K965170.

When did ROCCOBAROCCO & PRO-DYNAMIX receive FDA 510(k) clearance?

ROCCOBAROCCO & PRO-DYNAMIX received FDA 510(k) clearance on 1997-03-11, under 510(k) number K965170.

Who is the listed applicant for ROCCOBAROCCO & PRO-DYNAMIX?

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

What is the FDA product code for ROCCOBAROCCO & PRO-DYNAMIX?

The FDA product code for ROCCOBAROCCO & PRO-DYNAMIX is HQY.

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

Related Devices (Code: HQY)

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.

K974852NON-PRESCRIPTION SUNGLASSESChia Hui Spectacles Mfg. Corp.K974860NON-PRESCRIPTION SUNGLASSESWenzhou Ming Ming Optical Co. , Ltd.K974861NON-PRESCRIPTION SUNGLASSESWenzhou Hindar Optical Co., Ltd.K974511SUNGLASSESSun World Intl., Inc.K974441SUNGLASSESHip Shing Fat Co., Ltd.K973528SUNGLASSESJeou Jeou Long Industrial Co., Ltd.

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.

↑