Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes
FDA 510(k) K043278 · Teratech Corp.
510(k) numberK043278
Submission
- Device name
- Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes
- Applicant
- Teratech Corp.
Bainbridge Island, WA, US - Received
- November 26, 2004
- Decision date
- December 13, 2004
- 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 Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes cleared by the FDA?
Teratech Model 8IOC4, 8IOL4 & 10LAP4 Probes (K043278) received a 510(k) decision of Substantially Equivalent on December 13, 2004, 17 days after the submission was received.
What is the product code of K043278?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.