510(k) K822135
K822135 is an FDA 510(k) premarket notification submitted by Seca Corp. for the device "SECA DIGITAL BABY SCALE 727". The FDA issued a decision of Substantially Equivalent on Jul 30, 1982. The device falls under product code FRW (Scale, Patient), a Class I device regulated under 21 CFR 880.2720. Seca Corp. has 2 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 30, 1982
- Date Received
- Jul 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Scale, Patient
- Device Class
- Class I
- Regulation Number
- 880.2720
- Review Panel
- HO
- Submission Type
- 510(k) Exempt