510(k) K911191
K911191 is an FDA 510(k) premarket notification submitted by Palco Laboratories, Inc. for the device "PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR". The FDA issued a decision of Substantially Equivalent on Jun 10, 1991. The device falls under product code DQA (Oximeter), a Class II device regulated under 21 CFR 870.2700. Palco Laboratories, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 10, 1991
- Date Received
- Mar 18, 1991
- 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)