Interface Module Iddd
FDA 510(k) K992635 · Stoeckert Instrumente
510(k) numberK992635
Submission
- Device name
- Interface Module Iddd
- Applicant
- Stoeckert Instrumente
North Attleboro, MA, US - Received
- August 6, 1999
- Decision date
- December 20, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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 |
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| K874605 | Hi-Lo Temp(R) Myocardial Temperature SensorKRI · Traditional | Mallinckrodt Critical Care | 02/02/1988SE |
| K874925 | Cpe 2000 Cardio Pulmonary ErgometerKRI · Traditional | Medical Graphics Corp. | 01/19/1988SE |
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Questions and answers
When was Interface Module Iddd cleared by the FDA?
Interface Module Iddd (K992635) received a 510(k) decision of Substantially Equivalent on December 20, 1999, 136 days after the submission was received.
What is the product code of K992635?
The FDA product code is KRI – Accessory Equipment, Cardiopulmonary Bypass, a Class I (low risk) device regulated under 21 CFR 870.4200.