Lifecard CF 7 Day
FDA 510(k) K011837 · Reynolds Medical , Ltd.
510(k) numberK011837
Submission
- Device name
- Lifecard CF 7 Day
- Applicant
- Reynolds Medical , Ltd.
Hasbrouck, NJ, US - Received
- June 12, 2001
- Decision date
- July 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MWJ – Electrocardiograph, Ambulatory (Without Analysis)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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More from Medicalgorithmics S.A.
| 510(k) | Device | Decision |
|---|---|---|
| K024283 | Cardiodirect, Models 12M, 12I, 12SDPS · Traditional | 08/01/2003SE |
| K013367 | Cardiocollect Portable ElectrocardiographDPS · Traditional | 12/13/2001SE |
| K011345 | Cardionavigator Information Management SystemDXH · Traditional | 07/20/2001SE |
| K001025 | Lifecard CF Compact RecorderDSH · Special | 04/19/2000SE |
| K991211 | Eventstation ECG Trans-Telephonic Receiving SystemDXH · Traditional | 07/08/1999SE |
| K972649 | Cardiocall Cardiac Event RecorderDXH · Traditional | 12/04/1997SE |
| K951902 | Pathfinder 700 Holter AnalyzerDQK · Traditional | 07/15/1996SE |
| K943278 | Tracker 2/TRACKER 3 Holter RecorderDSH · Traditional | 10/20/1994SE |
| K884126 | E-RamDSH · Traditional | 10/30/1989SE |
| K871344 | Pathfinder 3, Auto Surveyor and SurveyorDSI · Traditional | 10/20/1987SE |
Questions and answers
When was Lifecard CF 7 Day cleared by the FDA?
Lifecard CF 7 Day (K011837) received a 510(k) decision of Substantially Equivalent on July 13, 2001, 31 days after the submission was received.
What is the product code of K011837?
The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.