FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
K Number: K250093
·
Decision Sep 26, 2025
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
174
Applicant Total
2
Review Days
255
Basic Information
- Device Name
- Linshom Continuous Predictive Respiratory Monitoring System (CPRMS)
- K Number
- K250093
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2375
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linshom Medical, Inc.
- Date Received
- January 14, 2025
- Decision Date
- September 26, 2025
- Product Code
- BZQ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | FDA class 2 | Anesthesiology |
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Other Clearances by Linshom Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240271 | Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) | Sep 11, 2024 | Substantially Equivalent |