Standard Polysomnograph With Electroencephalograph
Regulation 882.1400
2510(k)s in 12 months (65 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OLV
| Company | 510(k)s | Recalls |
|---|---|---|
| Nihon Kohden America, Inc. | 9 | 0 |
| Neurotronics, Inc. | 5 | 0 |
| Grass-Telefactor Product Group | 4 | 0 |
| Bio-Logic Systems Corp. | 3 | 0 |
| Airsep Corp. | 2 | 0 |
| Astro-Med, Inc. | 2 | 0 |
| Biosys AB (Publ) | 2 | 0 |
| Compumedics Limited | 2 | 0 |
| Excel Tech. , Ltd. | 2 | 0 |
| Grass Instrument Co. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 1999 | K990522 | WARATAH DIGITAL EEG AND SLEEP ACQUISITION DEVICES WITH, OR WITHOUT, PULSE OXIMETRY,CARDINAL DIGITAL EEG AND SLEEP ACQUIS Lamont Medical, Inc. | OLV |
| Mar 12, 1999 | K984580 | BIOSACA SYSTEM Biosys AB (Publ) | OLV |
| Dec 1, 1998 | K983072 | AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 Nihon Kohden America, Inc. | OLV |
| Nov 25, 1998 | K983913 | MODIFICATION TO BIO-LOGIC SLEEPSCAN Bio-Logic Systems Corp. | OLV |
| Jun 9, 1998 | K974583 | DEEGLITE Grass-Telefactor Product Group | OLV |
| Mar 9, 1998 | K974587 | H2O Grass-Telefactor Product Group | OLV |
| Jan 16, 1998 | K971813 | EMBLA Ferguson Medical | OLV |
| Aug 13, 1997 | K971867 | ALICE 4R SYSTEM Healthdyne Technologies, Inc. | OLV |
| May 19, 1997 | K970951 | GRASS BRAINWAVE SOFTWARE Astro-Med, Inc. | OLV |
| Jan 17, 1997 | K961638 | MEDILOG MPA-S Oxford Instruments Medical Systems | OLV |
| Jul 6, 1994 | K922106 | ALICE Healthdyne, Inc. | OLV |
| Jan 27, 1994 | K934599 | SANDMAN Melville Software , Ltd., CA | OLV |
| Aug 12, 1986 | K860458 | ELECTROPHYSIOLOGICAL SYSTEM TO MONITOR SKIN TEMP. Oxford Medilog, Inc. | OLV |
| Jun 5, 1986 | K854665 | 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH Nihon Kohden America, Inc. | OLV |
| Apr 17, 1986 | K860219 | SASSSY SEMI AUTOMATIC SLEEP SCORING SYSTEM Grass-Telefactor Product Group | OLV |
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