Disposable Temporary Pacing Cable,Models CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5
FDA 510(k) K022075 · Cp Medical
510(k) numberK022075
Submission
- Device name
- Disposable Temporary Pacing Cable,Models CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5
- Applicant
- Cp Medical
Portland, OR, US - Received
- June 26, 2002
- Decision date
- September 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSA – Cable, Transducer And Electrode, Patient, (Including Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2900
- Specialty
- Cardiovascular
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Questions and answers
When was Disposable Temporary Pacing Cable,Models CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 cleared by the FDA?
Disposable Temporary Pacing Cable,Models CPW-BV-5,CPW-LG-5,CPW-SM-5,CPW-ERA300-5,CPW-QLOC-5 (K022075) received a 510(k) decision of Substantially Equivalent on September 19, 2002, 85 days after the submission was received.
What is the product code of K022075?
The FDA product code is DSA – Cable, Transducer And Electrode, Patient, (Including Connector), a Class II (moderate risk) device regulated under 21 CFR 870.2900.