R2 Apex-Post.,Ant.&Post. ELECT.(12 Mods)
FDA 510(k) K800935 · R2 Corp.
510(k) numberK800935
Submission
- Device name
- R2 Apex-Post.,Ant.&Post. ELECT.(12 Mods)
- Applicant
- R2 Corp.
Walker, MI, US - Received
- April 21, 1980
- Decision date
- May 23, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K832516 | Magnatrode Cardiac Monitoring ElectrodeDRX · Traditional | 12/16/1983SE |
| K800937 | R2 Plate Type Cable-Adaptor #S 175,176LDD · Traditional | 05/23/1980SE |
| K800936 | R2 Paddle Type Cable-Adaptor #S 170,171LDD · Traditional | 05/23/1980SE |
| K800932 | Ecg-Rf-Choke Cable-Adapter #'S 121,120DSA · Traditional | 05/23/1980SE |
| K800931 | R2(TM) ECG Cable-Adaptor #'S 120-121-122DSA · Traditional | 05/23/1980SE |
| K800930 | R2(TM) ECG Electrode SET-#'S305-306 Etc.DRX · Traditional | 05/23/1980SE |
| K800934 | R2 Esu Cable-Adapter Models 160,161IKD · Traditional | 05/20/1980SE |
| K800933 | R2 Electrosurg. Return Elect. #225ETC.JOT · Traditional | 05/20/1980SE |
Questions and answers
When was R2 Apex-Post.,Ant.&Post. ELECT.(12 Mods) cleared by the FDA?
R2 Apex-Post.,Ant.&Post. ELECT.(12 Mods) (K800935) received a 510(k) decision of Substantially Equivalent on May 23, 1980, 32 days after the submission was received.
What is the product code of K800935?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.