Arbo H85V/H87V/H27V Dispos Monit Electrodes
FDA 510(k) K935437 · Arbo Medical, Inc.
510(k) numberK935437
Submission
- Device name
- Arbo H85V/H87V/H27V Dispos Monit Electrodes
- Applicant
- Arbo Medical, Inc.
Stratford, CT, US - Received
- November 10, 1993
- Decision date
- April 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K935246 | Arbo H49P, H59P Disposable Monitoring ElectrodesDRX · Traditional | 11/16/1994SE |
| K935429 | Arbo H90, H91, H135 Disposable Monitoring ElectrodesDRX · Traditional | 11/01/1994SE |
| K935281 | Arbo H87P, H85P, H27P Disposable Monitoring ElectrodesDRX · Traditional | 09/06/1994SE |
| K905545 | Ultrasound Transmission GelJOT · Traditional | 03/29/1991SE |
| K902788 | Clem TMFIB · Traditional | 09/12/1990SE |
| K901816 | Pressure Tubing and AccessoriesCAH · Traditional | 07/12/1990SE |
Questions and answers
When was Arbo H85V/H87V/H27V Dispos Monit Electrodes cleared by the FDA?
Arbo H85V/H87V/H27V Dispos Monit Electrodes (K935437) received a 510(k) decision of Substantially Equivalent on April 6, 1995, 512 days after the submission was received.
What is the product code of K935437?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.