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)

BABY BOARD

K-Number: K935098 · 1994-02-15

ApplicantSentry Medical Products, Inc.
Decision Date1994-02-15
Product CodeBTX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BABY BOARD is the device name listed in this FDA 510(k) record. The listed applicant is Sentry Medical Products, Inc.. It received FDA 510(k) clearance on 1994-02-15 under 510(k) number K935098. The device is classified under product code BTX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BABY BOARD?

BABY BOARD is a medical device that received FDA 510(k) clearance on 1994-02-15. The listed applicant is Sentry Medical Products, Inc.. The 510(k) number is K935098.

When did BABY BOARD receive FDA 510(k) clearance?

BABY BOARD received FDA 510(k) clearance on 1994-02-15, under 510(k) number K935098.

Who is the listed applicant for BABY BOARD?

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

What is the FDA product code for BABY BOARD?

The FDA product code for BABY BOARD is BTX.

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 Sentry Medical 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.

K962122SENTRY RADIOTRANSLUCENT ECG ELECTRODESK955636SENTRY DISPOSABLE DISPERSIVE ELECTRODEK942827SENTRY INSERTION TRAYK934000SENTRY AQUEOUS GEL ECG ELECTRODESK933603LEADWIREK932704PATIENT CABLE

View all 13 devices →

Related Devices (Code: BTX)

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.

K9001754/1 ARMBOARDInfection Control Products, Inc.K884838ALLEN PRONE ARMBOARDEdgewater Medical Systems, Inc.K882524UNIVERSALLY ADJUSTABLE ARMBOARDKarlin Technology, Inc.K881292ALLEN LATERAL ARMBOARDEdgewater Medical Systems, Inc.K864670BOARD, ARM (WITH COVER)Anago, Inc.K833664ARMBOARD AND THE BOARDRick Robbin & Frederick Auerbach

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.

↑