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)

DANMAR PRODUCTS MICHIGAN CRANIAL HELMET

K-Number: K003630 · 2001-05-29

ApplicantDanmar Products, Inc.
Decision Date2001-05-29
Product CodeMVA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DANMAR PRODUCTS MICHIGAN CRANIAL HELMET is the device name listed in this FDA 510(k) record. The listed applicant is Danmar Products, Inc.. It received FDA 510(k) clearance on 2001-05-29 under 510(k) number K003630. The device is classified under product code MVA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DANMAR PRODUCTS MICHIGAN CRANIAL HELMET?

DANMAR PRODUCTS MICHIGAN CRANIAL HELMET is a medical device that received FDA 510(k) clearance on 2001-05-29. The listed applicant is Danmar Products, Inc.. The 510(k) number is K003630.

When did DANMAR PRODUCTS MICHIGAN CRANIAL HELMET receive FDA 510(k) clearance?

DANMAR PRODUCTS MICHIGAN CRANIAL HELMET received FDA 510(k) clearance on 2001-05-29, under 510(k) number K003630.

Who is the listed applicant for DANMAR PRODUCTS MICHIGAN CRANIAL HELMET?

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

What is the FDA product code for DANMAR PRODUCTS MICHIGAN CRANIAL HELMET?

The FDA product code for DANMAR PRODUCTS MICHIGAN CRANIAL HELMET is MVA.

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 Danmar Products, 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.

K090341MICHIGAN CRANIAL RESHAPING ORTHOSISK013452DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS

Related Devices (Code: MVA)

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.

K241957Talee, Talee PostOpInvent Medical USA, LLCK230444Talee, Talee PostOpInvent Medical USA, LLCK223238STARband 3DOrthomerica Products, Inc.K220681Talee, Talee PostOPInvent Medical USA, LLCK203134Hanger Cranial Band 3DSymbion Logistics, LLCK213587MyCRO BandOtto Bock Healthcare LP

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.

↑