Concept CCT-5200, Thermal Therapy System
FDA 510(k) K884255 · Concept, Inc.
510(k) numberK884255
Submission
- Device name
- Concept CCT-5200, Thermal Therapy System
- Applicant
- Concept, Inc.
Largo, FL, US - Received
- October 11, 1988
- Decision date
- November 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ILO – Pack, Hot Or Cold, Water Circulating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5720
- Specialty
- Physical Medicine
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Questions and answers
When was Concept CCT-5200, Thermal Therapy System cleared by the FDA?
Concept CCT-5200, Thermal Therapy System (K884255) received a 510(k) decision of Substantially Equivalent on November 8, 1988, 28 days after the submission was received.
What is the product code of K884255?
The FDA product code is ILO – Pack, Hot Or Cold, Water Circulating, a Class II (moderate risk) device regulated under 21 CFR 890.5720.