510(k) K864827
K864827 is an FDA 510(k) premarket notification submitted by Tactilitics, Inc. for the device "RSVP SYSTEMS, SERIES I, BED-PATIENT MONITOR". The FDA issued a decision of Substantially Equivalent on January 21, 1987. The device falls under product code KMI (Monitor, Bed Patient), a Class I device regulated under 21 CFR 880.2400. Tactilitics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 1987
- Date Received
- December 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Monitor, Bed Patient
- Device Class
- Class I
- Regulation Number
- 880.2400
- Review Panel
- HO
- Submission Type