Pure EP
510(k) K180805
Pure EP is a Class II device made by Biosig Technologies, cleared under FDA 510(k) K180805 on 8 Aug 2018, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK180805 | Date8 Aug 2018 | StatusActive |
Official records
- FDA 510(k) database K180805
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQK
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1425
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K180805
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Pure EP - 5 x 10 pin Yoked Jumper Cable Blue PE-002-020-005 | PE-002-020-005 / PE-002-020-005 | 00856750007147 | — | On the market |
| Pure EP - 5 x 10 pin Yoked Jumper Cable Green PE-002-018-005 | PE-002-018-005 / PE-002-018-005 | 00856750007154 | — | On the market |
| Pure EP - 5 x 10 pin Yoked Jumper Cable White PE-002-019-005 | PE-002-019-005 / PE-002-019-005 | 00856750007130 | — | On the market |
| Pure EP - 5 x 4 pin Yoked Jumper Cable Red PE-002-016-005 | PE-002-016-005 / PE-002-016-005 | 00856750007178 | — | On the market |
| Pure EP - 5 x 4 pin Yoked Jumper Cable Yellow PE-002-015-005 | PE-002-015-005 / PE-002-015-005 | 00856750007161 | — | On the market |
| Pure EP - 5 x Single Jumper Cable Black 0.1m PE-002-017-005 | PE-002-017-005 / PE-002-017-005 | 00856750007116 | — | On the market |
| Pure EP - 5 x Single Jumper Cable Black 0.3m PE-002-014-005 | PE-002-014-005 / PE-002-014-005 | 00856750007109 | — | On the market |
| Pure EP - 5 x Single Jumper Cable Red 0.3m PE-002-013-005 | PE-002-013-005 / PE-002-013-005 | 00856750007093 | — | On the market |
| Pure EP - Catheter Input Module PE-002-006-000 | PE-002-006-000 / PE-002-006-000 | 00856750007031 | — | On the market |
| Pure EP - Catheter Input Module PE-002-007-000 | PE-002-007-000 / PE-002-007-000 | 00856750007048 | — | On the market |
| Pure EP - Dual ECG Splitter Box PE-002-021-000 | PE-002-021-000 / PE-002-021-000 | 00856750007123 | — | On the market |
| Pure EP - ECG Cable PE-002-008-000 | PE-002-008-000 / PE-002-008-000 | 00856750007055 | — | On the market |
| Pure EP AE-0001-412 | AE-0001-412 / AE-0001-412 | 08567500070008 | — | No longer on the market |
| Pure EP AE-0001-412 | PE-002-001-000 / AE-0001-412 | 00856750007000 | — | On the market |
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