H2O
FDA 510(k) K974587 · Grass-Telefactor Product Group
510(k) numberK974587
Submission
- Device name
- H2O
- Applicant
- Grass-Telefactor Product Group
West Conshohocken, PA, US - Received
- December 9, 1997
- Decision date
- March 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLV – Standard Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
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| K925838 | Telefactor D/EEG-32GWQ · Traditional | 04/30/1993SE |
| K884937 | BEEHIVE-64 or BEEHIVE-32, Digital EEG RecordingEEG · Traditional | 04/14/1989SE |
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| K871480 | STD-228 Spectral Trend DisplayGWS · Traditional | 05/01/1987SE |
| K870450 | SZAC-16 Seizure Analysis ComputerOMB · Traditional | 04/08/1987SE |
| K870381 | DD-VCR-64GWK · Traditional | 03/25/1987SE |
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Questions and answers
When was H2O cleared by the FDA?
H2O (K974587) received a 510(k) decision of Substantially Equivalent on March 9, 1998, 90 days after the submission was received.
What is the product code of K974587?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.