Dual Radiation Targeting System DRTS Drape
FDA 510(k) K973162 · Hogan & Hartson
510(k) numberK973162
Submission
- Device name
- Dual Radiation Targeting System DRTS Drape
- Applicant
- Hogan & Hartson
Washington, DC, US - Received
- August 22, 1997
- Decision date
- November 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Dual Radiation Targeting System DRTS Drape cleared by the FDA?
Dual Radiation Targeting System DRTS Drape (K973162) received a 510(k) decision of Substantially Equivalent on November 20, 1997, 90 days after the submission was received.
What is the product code of K973162?
The FDA product code is IWE – Monitor, Patient Position, Light-Beam, a Class I (low risk) device regulated under 21 CFR 892.5780.