510(k) K903991
K903991 is an FDA 510(k) premarket notification submitted by Siemens Life Support Systems for the device "PCM ANESTHESIA". The FDA issued a decision of Substantially Equivalent on February 25, 1991. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Siemens Life Support Systems has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1991
- Date Received
- August 29, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type