Adult ECG Electrode #60-0724
FDA 510(k) K810103 · Aspen Laboratories, Inc.
510(k) numberK810103
Submission
- Device name
- Adult ECG Electrode #60-0724
- Applicant
- Aspen Laboratories, Inc.
Mchenry, IL, US - Received
- January 16, 1981
- Decision date
- January 29, 1981
- 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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| K960296 | 4000 EtmGEI · Traditional | 02/20/1996SE |
| K953081 | Beamer PlusGEI · Traditional | 10/30/1995SE |
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| K946104 | Smokievac Electrosurgical PencilGEI · Traditional | 04/03/1995SE |
| K944012 | Electrosurgical Flexible Electrode In-Line Suction CoagulatorGEI · Traditional | 12/21/1994SE |
| K924960 | Excalibur Electrosurgical UnitGEI · Traditional | 04/16/1993SE |
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Questions and answers
When was Adult ECG Electrode #60-0724 cleared by the FDA?
Adult ECG Electrode #60-0724 (K810103) received a 510(k) decision of Substantially Equivalent on January 29, 1981, 13 days after the submission was received.
What is the product code of K810103?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.