510(k) K946185
K946185 is an FDA 510(k) premarket notification submitted by Bci Intl., Inc. for the device "3301T OXITEMP". The FDA issued a decision of Substantially Equivalent on March 17, 1995. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Bci Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1995
- Date Received
- December 20, 1994
- 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