Series 620 Rectal Probe Cover
FDA 510(k) K864222 · General Electric Co.
510(k) numberK864222
Submission
- Device name
- Series 620 Rectal Probe Cover
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- October 28, 1986
- Decision date
- March 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Series 620 Rectal Probe Cover cleared by the FDA?
Series 620 Rectal Probe Cover (K864222) received a 510(k) decision of Substantially Equivalent on March 4, 1987, 127 days after the submission was received.
What is the product code of K864222?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.