Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound System
FDA 510(k) K011314 · Aloka Co., Ltd.
510(k) numberK011314
Submission
- Device name
- Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound System
- Applicant
- Aloka Co., Ltd.
Wallingford, CT, US - Received
- April 30, 2001
- Decision date
- May 15, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound System cleared by the FDA?
Olympus GF UC140P-AL5 Ultrasonic Endoscope with Aloka SSD-5500 Ultrasound System (K011314) received a 510(k) decision of Substantially Equivalent on May 15, 2001, 15 days after the submission was received.
What is the product code of K011314?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.