Natural Rubber Latex Ultrasound Transducer Probe Covers
FDA 510(k) K213087 · Global Protection Corp.
510(k) numberK213087
Submission
- Device name
- Natural Rubber Latex Ultrasound Transducer Probe Covers
- Applicant
- Global Protection Corp.
Boston, MA, US - Received
- September 24, 2021
- Decision date
- June 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Natural Rubber Latex Ultrasound Transducer Probe Covers cleared by the FDA?
Natural Rubber Latex Ultrasound Transducer Probe Covers (K213087) received a 510(k) decision of Substantially Equivalent on June 7, 2022, 256 days after the submission was received.
What is the product code of K213087?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.