Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
FDA 510(k) clearance K213316 · decided 2021-12-29
Clearance details
- K-number
- K213316
- Device name
- Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM
- Applicant
- Nihon Kohden Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-10-04
- Decision date
- 2021-12-29
- Days to decision
- 86 days
- Clearance type
- Special
- Product code
- KOI
- Device class
- 2
- Regulation number
- 868.2775
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Nihon Kohden Corporation
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.