510(k) K011156
K011156 is an FDA 510(k) premarket notification submitted by Bci, Inc. for the device "BCI 3403 SLEEP SCREENING PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on June 14, 2001. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Bci, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2001
- Date Received
- April 16, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Oximeter
- Device Class
- Class II
- Regulation Number
- 870.2700
- Review Panel
- AN
- Submission Type