SDU-700 Phased Array Sector and Linear Scanner
FDA 510(k) K873674 · Shimadzu Corp.
510(k) numberK873674
Submission
- Device name
- SDU-700 Phased Array Sector and Linear Scanner
- Applicant
- Shimadzu Corp.
Kyoto City 604 Japan, JP - Received
- September 11, 1987
- Decision date
- October 7, 1988
- 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 SDU-700 Phased Array Sector and Linear Scanner cleared by the FDA?
SDU-700 Phased Array Sector and Linear Scanner (K873674) received a 510(k) decision of Substantially Equivalent on October 7, 1988, 392 days after the submission was received.
What is the product code of K873674?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.