Medi-Trace 200, Medi-Trace 200-30
FDA 510(k) K960968 · Graphic Controls Corp.
510(k) numberK960968
Submission
- Device name
- Medi-Trace 200, Medi-Trace 200-30
- Applicant
- Graphic Controls Corp.
Buafflo, NY, US - Received
- March 11, 1996
- Decision date
- October 28, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K981964 | Medi-Trace 4103 Neonatal ElectrodeDRX · Traditional | 11/13/1998SE |
| K983287 | Medi-Trace 1610C Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 11/05/1998SE |
| K974730 | Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)KXO · Traditional | 07/14/1998SE |
| K980857 | Medi-Trace 1310P Combination Defibrillation, Monitoring & Pacing ElectrodeMKJ · Traditional | 05/12/1998SE |
| K972970 | Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 08/27/1997SE |
| K964387 | Point of Use II Sharps-A-GatorMMK · Traditional | 03/27/1997SE |
| K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional | 01/22/1997SE |
| K963151 | Medi-Trace 5700 Resting ECG ElectrodeDRX · Traditional | 11/19/1996SE |
| K963038 | Medi-Trace 3600 Series of ECG Monitoring ElectrodeDRX · Traditional | 11/15/1996SE |
| K955923 | Medi-Trace Combination Defibrillation & ECG Electrode for LaerdalMKJ · Traditional | 10/24/1996SE |
Questions and answers
When was Medi-Trace 200, Medi-Trace 200-30 cleared by the FDA?
Medi-Trace 200, Medi-Trace 200-30 (K960968) received a 510(k) decision of Substantially Equivalent on October 28, 1996, 231 days after the submission was received.
What is the product code of K960968?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.