510(k) K860254
K860254 is an FDA 510(k) premarket notification submitted by Healthdyne, Inc. for the device "HEALTHDYNE'S EVENT RECORDER SYSTEM". The FDA issued a decision of Substantially Equivalent on January 30, 1986. The device falls under product code BZQ (Monitor, Breathing Frequency), a Class II device regulated under 21 CFR 868.2375. Healthdyne, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1986
- Date Received
- January 24, 1986
- 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