A5 ANESTHESIA DELIVERY SYSTEM
FDA 510(k) clearance K123211 · decided 2013-02-14
Clearance details
- K-number
- K123211
- Device name
- A5 ANESTHESIA DELIVERY SYSTEM
- Applicant
- Datascope Corp., Patient Monitoring Division
- Decision
- Substantially Equivalent
- Date received
- 2012-10-12
- Decision date
- 2013-02-14
- Days to decision
- 125 days
- Clearance type
- Abbreviated
- Product code
- BSZ
- Device class
- 2
- Regulation number
- 868.5160
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mahwh, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.