Conmed ECG Patient Safety Cables and Leadwires-Removal and Permanently-Attached Leadwires
FDA 510(k) K945034 · Conmedcorp
510(k) numberK945034
Submission
- Device name
- Conmed ECG Patient Safety Cables and Leadwires-Removal and Permanently-Attached Leadwires
- Applicant
- Conmedcorp
Utica, NY, US - Received
- October 13, 1994
- Decision date
- October 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Conmed ECG Patient Safety Cables and Leadwires-Removal and Permanently-Attached Leadwires cleared by the FDA?
Conmed ECG Patient Safety Cables and Leadwires-Removal and Permanently-Attached Leadwires (K945034) received a 510(k) decision of Substantially Equivalent on October 27, 1994, 14 days after the submission was received.
What is the product code of K945034?
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.