510(k) K001770
K001770 is an FDA 510(k) premarket notification submitted by Bci, Inc. for the device "BCI M4529A OEM DIGITAL HANDHELD OXIMETER, MODEL M4529A". The FDA issued a decision of Substantially Equivalent on July 5, 2000. 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
- July 5, 2000
- Date Received
- June 12, 2000
- Clearance Type
- Special
- 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