Accutherm PTS-200

FDA 510(k) K890575 · Medical Repackers Co.

Substantially Equivalent

510(k) numberK890575

Submission

Device name
Accutherm PTS-200
Applicant
Medical Repackers Co.
Fort Payne, AL, US
Received
February 6, 1989
Decision date
May 5, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DWJ – System, Thermal Regulating
Device class
Class II (moderate risk)
Regulation
21 CFR 870.5900
Specialty
Cardiovascular

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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Questions and answers

When was Accutherm PTS-200 cleared by the FDA?

Accutherm PTS-200 (K890575) received a 510(k) decision of Substantially Equivalent on May 5, 1989, 88 days after the submission was received.

What is the product code of K890575?

The FDA product code is DWJ – System, Thermal Regulating, a Class II (moderate risk) device regulated under 21 CFR 870.5900.