iTOF®
FDA 510(k) clearance K242525 · decided 2024-12-05
Clearance details
- K-number
- K242525
- Device name
- iTOF®
- Applicant
- Nerbio Medical Software Platforms, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-08-26
- Decision date
- 2024-12-05
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- KOI
- Device class
- 2
- Regulation number
- 868.2775
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- San Jose, CA, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nerbio Medical Software Platforms
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.