IOP8 Intra Operative Probe
FDA 510(k) K032315 · Huntleigh Healthcare, Inc.
510(k) numberK032315
Submission
- Device name
- IOP8 Intra Operative Probe
- Applicant
- Huntleigh Healthcare, Inc.
Cardiff, GB - Received
- July 28, 2003
- Decision date
- November 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was IOP8 Intra Operative Probe cleared by the FDA?
IOP8 Intra Operative Probe (K032315) received a 510(k) decision of Substantially Equivalent on November 18, 2004, 479 days after the submission was received.
What is the product code of K032315?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.