510(k) K160481
- Device
- Vivo 60
- Applicant
- BREAS MEDICAL AB
- 510(k) number
- K160481
- Product code
- NOU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-11-09
- Date received
- 2016-02-22
- Regulation
- 868.5895
- Classification name
- Continuous, Ventilator, Home Use
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Albert Cefalo
- Address
- Foretagsvagen 1 Molnlycke Vastra Gotalands Lan SE 435 33 435 33
FDA Registration Numbers#
- 3011120183
- 3042507287
- 3007573469
- 3010817335
- 3009077524
- 8020893
- 3018783526
- 3033526676
- 1316463
- 3013095415
- 3011205710
- 3000126629
- 2518422
- 3002797442
- 3020283264
- 3007344957
- 9617566
- 3003135857
- 3004428458
- 3017520736
- 3029227324
- 3018094310
- 3004604967
- 3006087789
- 3023272766
- 9615827
- 1225492
- 2024500
- 3001400310
- 1000604079
Source Documents#
Other 510(k) Records For Product Code NOU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233452 | Vivo 45 LS | Breas Medical AB | 2025-01-13 |
| K193586 | Vivo 45 LS | Breas Medical AB | 2021-01-27 |
| K123144 | VIVO 50 | Ge Healthcare, Breas Medical AB | 2013-06-18 |
| K034032 | PLV CONTINUUM VENTILATOR, MODEL P2000 | Respironics California, Inc. | 2004-03-16 |
| K022750 | PLV CONTINUUM VENTILATOR, MODEL P1000 | Respironics California, Inc. | 2003-11-20 |
| K021981 | IVENT 201 PORTABLE VENTILATOR | Versamed , Ltd. | 2003-08-13 |
Legacy Summary#
summary
FDA Review#
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