510(k) K052186
K052186 is an FDA 510(k) premarket notification submitted by Nellcor Puritan Bennett, Inc. for the device "NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P". The FDA issued a decision of Substantially Equivalent on November 10, 2005. 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
- November 10, 2005
- Date Received
- August 11, 2005
- 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