N/A
FDA 510(k) K970590 · North American Technical Services Corp.
510(k) numberK970590
Submission
- Device name
- N/A
- Applicant
- North American Technical Services Corp.
Sound Beach, NY, US - Received
- February 18, 1997
- Decision date
- June 13, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ILY – Lamp, Infrared, Therapeutic Heating
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5500
- Specialty
- Physical Medicine
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Questions and answers
When was N/A cleared by the FDA?
N/A (K970590) received a 510(k) decision of Substantially Equivalent on June 13, 1997, 115 days after the submission was received.
What is the product code of K970590?
The FDA product code is ILY – Lamp, Infrared, Therapeutic Heating, a Class II (moderate risk) device regulated under 21 CFR 890.5500.