Video Annotator Model PK2310
FDA 510(k) K910384 · Perkins Mfg. Co.
510(k) numberK910384
Submission
- Device name
- Video Annotator Model PK2310
- Applicant
- Perkins Mfg. Co.
Dallas, TX, US - Received
- January 29, 1991
- Decision date
- April 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Video Annotator Model PK2310 cleared by the FDA?
Video Annotator Model PK2310 (K910384) received a 510(k) decision of Substantially Equivalent on April 16, 1991, 77 days after the submission was received.
What is the product code of K910384?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.