510(k) K021089
K021089 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett, Inc. for the device "OXIMAX MAX-FAST ADHESIVE FOREHEAD SENSOR". The FDA issued a decision of Substantially Equivalent on June 19, 2002. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Nellcor Puritan Bennett, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2002
- Date Received
- April 4, 2002
- 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