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)

KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US

K-Number: K063501 · 2007-04-06

ApplicantMallinckrodt Developpement France
Decision Date2007-04-06
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Developpement France. It received FDA 510(k) clearance on 2007-04-06 under 510(k) number K063501. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US?

KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US is a medical device that received FDA 510(k) clearance on 2007-04-06. The listed applicant is Mallinckrodt Developpement France. The 510(k) number is K063501.

When did KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US receive FDA 510(k) clearance?

KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US received FDA 510(k) clearance on 2007-04-06, under 510(k) number K063501.

Who is the listed applicant for KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US?

The FDA 510(k) record lists Mallinckrodt Developpement France as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US?

The FDA product code for KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US is BZD.

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 Mallinckrodt Developpement France 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.

K082237PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO STK080439SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATEK071575SANDMAN INTROK042184GOODKNIGHT H20, MODEL M-114600-00K041819GOODKNIGHT 425, MODELM-114500-00K001845MALLINCKRODT, GOODKNIGHT 418S

View all 7 devices →

Related Devices (Code: BZD)

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.

K261262Altis Full Face MaskRespironics, Inc.K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical 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.

↑