Recorder, Dinmap, Model 950

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K771932 ↗

FDA Product Code

DSH

Device Class

Class II

Regulation

21 CFR Part 870.2800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Model 1051, Monitor

  Class II

  FDA 510(k) K790328 Active Cleared 2 Mar 1979

• Dinamap Model 846

  Class II

  FDA 510(k) K781053 Active Cleared 7 Sep 1978

• Model 902 Stand

  Class I

  FDA 510(k) K780759 Active Cleared 19 May 1978

• Electrode, Needle, Cfm

  Class II

  FDA 510(k) K781311 Active Cleared 21 Aug 1978

• Dinamap Model 855

  Class II

  FDA 510(k) K791159 Active Cleared 30 Jul 1979

• Dinamap Model 848

  Class II

  FDA 510(k) K781064 Active Cleared 7 Sep 1978

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• What is the Dinmap Model 950 used for?

  The Dinmap Model 950 is a magnetic tape recorder specifically designed for capturing and storing cardiovascular data. It supports diagnostic and monitoring applications in clinical settings by recording and preserving heart-related information for further analysis.

• Is the Dinmap Model 950 a single-use or reusable device?

  The Dinmap Model 950 is a reusable device. It is intended for repeated use in clinical environments, allowing healthcare providers to record cardiovascular data over multiple sessions without the need for disposal after each use.

• What regulatory pathway was followed for the Dinmap Model 950?

  The Dinmap Model 950 was reviewed under the FDA’s 510(k) clearance process, specifically through a traditional review pathway. It was classified as substantially equivalent (SESE) and received clearance under the product code DSH, with a classification of Class II. The device was reviewed by the Cardiovascular Advisory Committee.

• Does the Dinmap Model 950 have any specific sterility or MRI safety information?

  The provided data does not include specific details regarding sterility requirements or MRI safety for the Dinmap Model 950. Clinicians should follow standard infection control protocols and consult manufacturer guidelines for safe use in MRI environments.

• What regulatory framework applies to the Dinmap Model 950?

  The Dinmap Model 950 is regulated under the FDA’s classification system for medical devices, specifically under the regulatory framework for 'Recorder, Magnetic Tape, Medical' (870.2800). It is intended for cardiovascular use and adheres to the standards set for Class II devices.