510(k) K001708
K001708 is an FDA 510(k) premarket notification submitted by Respironics Georgia, Inc. for the device "PROFOX SOFTWARE, MODEL 920M-41". The FDA issued a decision of Substantially Equivalent on Mar 1, 2001. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Respironics Georgia, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 1, 2001
- Date Received
- Jun 5, 2000
- 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
- 510(k)