Electrode, Needle, CFM
FDA 510(k) K781311 · Applied Medical Research
510(k) numberK781311
Submission
- Device name
- Electrode, Needle, CFM
- Applicant
- Applied Medical Research
Mchenry, IL, US - Received
- July 31, 1978
- Decision date
- August 21, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|
| K800025 | Dinamap Research Monitor 1245DXN · Traditional | 02/01/1980SE |
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| K791159 | Dinamap Model 855DXN · Traditional | 07/30/1979SE |
| K790322 | Optional Accessory Foot Switch Model 100EBW · Traditional | 05/14/1979SE |
| K790328 | Model 1051, MonitorDXN · Traditional | 03/02/1979SE |
| K782073 | Dinamap Models 1160 and 1165DSK · Traditional | 02/23/1979SE |
| K781064 | Dinamap Model 848DSK · Traditional | 09/07/1978SE |
| K781053 | Dinamap Model 846DSK · Traditional | 09/07/1978SE |
| K780754 | Neonatal MonitorDXN · Traditional | 06/14/1978SE |
| K780759 | Model 902 StandFSH · Traditional | 05/19/1978SE |
Questions and answers
When was Electrode, Needle, CFM cleared by the FDA?
Electrode, Needle, CFM (K781311) received a 510(k) decision of Substantially Equivalent on August 21, 1978, 21 days after the submission was received.
What is the product code of K781311?
The FDA product code is GXZ – Electrode, Needle, a Class II (moderate risk) device regulated under 21 CFR 882.1350.