Dental X-Ray Unit Heliodent 70
FDA 510(k) K781288 · Siemens Corp.
510(k) numberK781288
Submission
- Device name
- Dental X-Ray Unit Heliodent 70
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- July 26, 1978
- Decision date
- September 11, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Dental X-Ray Unit Heliodent 70 cleared by the FDA?
Dental X-Ray Unit Heliodent 70 (K781288) received a 510(k) decision of Substantially Equivalent on September 11, 1978, 47 days after the submission was received.
What is the product code of K781288?
The FDA product code is EHD – Unit, X-Ray, Extraoral With Timer, a Class II (moderate risk) device regulated under 21 CFR 872.1800.