510(k) K924752
K924752 is an FDA 510(k) premarket notification submitted by Pro-Tech, Inc. for the device "FREEDOM OXIMETER/EEG DIGITAL INTERFACE". The FDA issued a decision of Substantially Equivalent on Sep 10, 1993. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Pro-Tech, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 10, 1993
- Date Received
- Sep 23, 1992
- 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)