510(k) K954267
K954267 is an FDA 510(k) premarket notification submitted by Burdick, Inc. for the device "BURDICK 200 PULSE OXIMETER". The FDA issued a decision of Substantially Equivalent on May 3, 1996. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Burdick, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 3, 1996
- Date Received
- September 12, 1995
- 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