SpassageQ
FDA 510(k) clearance K230386 · decided 2023-06-15
Clearance details
- K-number
- K230386
- Device name
- SpassageQ
- Applicant
- Spass, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-02-14
- Decision date
- 2023-06-15
- Days to decision
- 121 days
- Clearance type
- Traditional
- Product code
- PLB
- Device class
- 2
- Regulation number
- 870.2300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| AITRICS-VC (K240756) | Aitrics Co., Ltd. | 2024-07-23 |
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| Biovitals Analytics Engine (K183282) | Biofourmis Singapore Pte., Ltd. | 2019-08-15 |
| T3 Software (K152258) | Etiometry, Inc. | 2016-03-31 |
| Personalized Physiology Analytics Engine software (K142512) | Vgbio, Inc (Dba Physiq) | 2015-06-11 |
| TRAUMA CARE EVALUATION (K843905) | Quantitative | 1985-09-26 |
Recalls involving this device
No recalls on record reference this clearance.