EEG Telephone Receiver Model #Afr-J
FDA 510(k) K810872 · Telediagnostic Systems, Inc.
510(k) numberK810872
Submission
- Device name
- EEG Telephone Receiver Model #Afr-J
- Applicant
- Telediagnostic Systems, Inc.
Mchenry, IL, US - Received
- March 31, 1981
- Decision date
- May 1, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXH – Transmitters And Receivers, Electrocardiograph, Telephone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2920
- Specialty
- Cardiovascular
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| K884891 | OC-100 Oximeter Interface CalibratorDQA · Traditional | 12/28/1988SE |
| K883947 | ISO-100 Isolation AmplifierGYE · Traditional | 12/05/1988SE |
| K874257 | S-10 Telephonic PolysomnographGYE · Traditional | 12/11/1987SE |
| K871120 | M10 EEG Monitor ScopeGYE · Traditional | 05/01/1987SE |
Questions and answers
When was EEG Telephone Receiver Model #Afr-J cleared by the FDA?
EEG Telephone Receiver Model #Afr-J (K810872) received a 510(k) decision of Substantially Equivalent on May 1, 1981, 31 days after the submission was received.
What is the product code of K810872?
The FDA product code is DXH – Transmitters And Receivers, Electrocardiograph, Telephone, a Class II (moderate risk) device regulated under 21 CFR 870.2920.