510(k) K770847
K770847 is an FDA 510(k) premarket notification submitted by Sr Instruments, Inc. for the device "PORTA-SCALE". The FDA issued a decision of Substantially Equivalent on June 8, 1977. The device falls under product code FRI (Scale, Stand-On, Patient), a Class I device regulated under 21 CFR 880.2700. Sr Instruments, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 8, 1977
- Date Received
- May 9, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scale, Stand-On, Patient
- Device Class
- Class I
- Regulation Number
- 880.2700
- Review Panel
- HO
- Submission Type