Vista Polysomnography Computer System
FDA 510(k) K904328 · Telediagnostic Systems, Inc.
510(k) numberK904328
Submission
- Device name
- Vista Polysomnography Computer System
- Applicant
- Telediagnostic Systems, Inc.
San Francisco, CA, US - Received
- September 20, 1990
- Decision date
- June 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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More from Bio-Feedback Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071661 | Alphaone Biofeedback SystemHCC · Traditional | 09/05/2007SE |
| K022249 | Nightron Polysomnography SystemOLV · Traditional | 12/31/2002SE |
| K970659 | DT-24 Telephonic EEG TRANSMITTER/DR-24 Telephonic EEG ReceiverGYE · Traditional | 05/16/1997SE |
| K904222 | Vista Graph Polysomnography AmplifierGWL · Traditional | 01/18/1991SE |
| K885328 | RS-10 Telephonic Polysomnography ReceiverGYE · Traditional | 03/22/1989SE |
| 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 |
| K810872 | EEG Telephone Receiver Model #Afr-JDXH · Traditional | 05/01/1981SE |
Questions and answers
When was Vista Polysomnography Computer System cleared by the FDA?
Vista Polysomnography Computer System (K904328) received a 510(k) decision of Substantially Equivalent on June 18, 1991, 271 days after the submission was received.
What is the product code of K904328?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.