The following data is part of a premarket notification filed by Cleveland Medical Devices, Inc. with the FDA for Family Of Crystal 20 Monitors Model #cs20-600,900,1300,1400,2400 & 120.
| Device ID | K042039 |
| 510k Number | K042039 |
| Device Name: | FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 |
| Classification | Standard Polysomnograph With Electroencephalograph |
| Applicant | CLEVELAND MEDICAL DEVICES, INC. 4415 EUCLID AVE Cleveland, OH 44103 |
| Contact | Robert N Schmidt |
| Correspondent | Robert N Schmidt CLEVELAND MEDICAL DEVICES, INC. 4415 EUCLID AVE Cleveland, OH 44103 |
| Product Code | OLV |
| CFR Regulation Number | 882.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-29 |
| Decision Date | 2004-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B143700001192 | K042039 | 000 |
| B14360200511 | K042039 | 000 |
| B14360200451 | K042039 | 000 |
| B14350202060 | K042039 | 000 |
| B143502020450 | K042039 | 000 |
| B143502020440 | K042039 | 000 |
| B143502020430 | K042039 | 000 |
| B143502020420 | K042039 | 000 |
| B143502020410 | K042039 | 000 |
| B14350201700 | K042039 | 000 |
| B143502016910 | K042039 | 000 |
| B14350201490 | K042039 | 000 |
| B143502014610 | K042039 | 000 |
| B14350201440 | K042039 | 000 |
| B143502012540 | K042039 | 000 |
| B14350101320 | K042039 | 000 |
| B14360200751 | K042039 | 000 |
| B14360200761 | K042039 | 000 |
| B143700001172 | K042039 | 000 |
| B143700001112 | K042039 | 000 |
| B1437000011112 | K042039 | 000 |
| B1437000011102 | K042039 | 000 |
| B143700000922 | K042039 | 000 |
| B143700000712 | K042039 | 000 |
| B14360201292 | K042039 | 000 |
| B14360201282 | K042039 | 000 |
| B14360201252 | K042039 | 000 |
| B14360201222 | K042039 | 000 |
| B14360201171 | K042039 | 000 |
| B14360201141 | K042039 | 000 |
| B14360201111 | K042039 | 000 |
| B14360201081 | K042039 | 000 |
| B14360200791 | K042039 | 000 |
| B14350100280 | K042039 | 000 |