510(k) K230386
- Device
- SpassageQ
- Applicant
- Spass, Inc.
- 510(k) number
- K230386
- Product code
- PLB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-15
- Date received
- 2023-02-14
- Regulation
- 870.2300
- Classification name
- Multivariate Vital Signs Index
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Yonghwan Kim
- Address
- Unit 905, 396 World Cup Buk-Ro, Mapo-Gu Seoul KR 03925 03925
FDA Registration Numbers#
- 3011683100
- 3034211429
- 3030597723
Source Documents#
Other 510(k) Records For Product Code PLB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240756 | AITRICS-VC | Aitrics Co., Ltd. | 2024-07-23 |
| K240558 | NAVOYCDS | Algodx AB | 2024-07-22 |
| K213423 | T3 Platform software | Etiometry, Inc. | 2023-01-06 |
| K183282 | Biovitals Analytics Engine | Biofourmis Singapore Pte., Ltd. | 2019-08-15 |
| K152258 | T3 Software | Etiometry, Inc. | 2016-03-31 |
| K142512 | Personalized Physiology Analytics Engine software | Vgbio, Inc (Dba Physiq) | 2015-06-11 |
| K843905 | TRAUMA CARE EVALUATION | Quantitative | 1985-09-26 |