510(k) K940014
K940014 is an FDA 510(k) premarket notification submitted by Pro-Tech, Inc. for the device "PLM SENSOR, MODEL PLM1". The FDA issued a decision of Substantially Equivalent - Subject to Tracking Reg. on Nov 10, 1994. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Pro-Tech, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- ST (Substantially Equivalent - Subject to Tracking Reg.)
- Decision Date
- Nov 10, 1994
- Date Received
- Jan 4, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Breathing Frequency
- Device Class
- Class II
- Regulation Number
- 868.2375
- Review Panel
- AN
- Submission Type
- 510(k)