3MHZ Annular Array
FDA 510(k) K864980 · Philips Ultrasound, Inc.
510(k) numberK864980
Submission
- Device name
- 3MHZ Annular Array
- Applicant
- Philips Ultrasound, Inc.
Santa Ana, CA, US - Received
- December 22, 1986
- Decision date
- May 11, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOP – Transducer, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2880
- Specialty
- Cardiovascular
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Questions and answers
When was 3MHZ Annular Array cleared by the FDA?
3MHZ Annular Array (K864980) received a 510(k) decision of Substantially Equivalent on May 11, 1987, 140 days after the submission was received.
What is the product code of K864980?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.