HP 21362B Transesophageal Ultrasound Imaging Trans
FDA 510(k) K884395 · Hewlett-Packard Co.
510(k) numberK884395
Submission
- Device name
- HP 21362B Transesophageal Ultrasound Imaging Trans
- Applicant
- Hewlett-Packard Co.
Andover, MA, US - Received
- October 18, 1988
- Decision date
- January 10, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was HP 21362B Transesophageal Ultrasound Imaging Trans cleared by the FDA?
HP 21362B Transesophageal Ultrasound Imaging Trans (K884395) received a 510(k) decision of Substantially Equivalent on January 10, 1989, 84 days after the submission was received.
What is the product code of K884395?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.