Cpe 2000 Cardio Pulmonary Ergometer
FDA 510(k) K874925 · Medical Graphics Corp.
510(k) numberK874925
Submission
- Device name
- Cpe 2000 Cardio Pulmonary Ergometer
- Applicant
- Medical Graphics Corp.
St. Paul, MN, US - Received
- December 2, 1987
- Decision date
- January 19, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRI – Accessory Equipment, Cardiopulmonary Bypass
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.4200
- Specialty
- Cardiovascular
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| K884893 | Cardiotomy Reservoir Valve No. CRV-30 or PCRV-25KRI · Traditional | American Omni Medical, Inc. | 01/30/1989SE |
| K884640 | Cardioplegia Overpressure Valve CPOP-350 & 700KRI · Traditional | American Omni Medical, Inc. | 01/24/1989SE |
| K874605 | Hi-Lo Temp(R) Myocardial Temperature SensorKRI · Traditional | Mallinckrodt Critical Care | 02/02/1988SE |
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Questions and answers
When was Cpe 2000 Cardio Pulmonary Ergometer cleared by the FDA?
Cpe 2000 Cardio Pulmonary Ergometer (K874925) received a 510(k) decision of Substantially Equivalent on January 19, 1988, 48 days after the submission was received.
What is the product code of K874925?
The FDA product code is KRI – Accessory Equipment, Cardiopulmonary Bypass, a Class I (low risk) device regulated under 21 CFR 870.4200.