Opti 110/12/50HSG
FDA 510(k) K810190 · Siemens Corp.
510(k) numberK810190
Submission
- Device name
- Opti 110/12/50HSG
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- January 23, 1981
- Decision date
- March 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Opti 110/12/50HSG cleared by the FDA?
Opti 110/12/50HSG (K810190) received a 510(k) decision of Substantially Equivalent on March 2, 1981, 38 days after the submission was received.
What is the product code of K810190?
The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.