510(k) K830273
K830273 is an FDA 510(k) premarket notification submitted by Ritmed, Inc. for the device "COUNTWAY SYS. SOILED SPONGES-BLOOD LOS". The FDA issued a decision of Substantially Equivalent on February 28, 1983. The device falls under product code FQA (Scale, Surgical Sponge), a Class I device regulated under 21 CFR 880.2740. Ritmed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1983
- Date Received
- January 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scale, Surgical Sponge
- Device Class
- Class I
- Regulation Number
- 880.2740
- Review Panel
- HO
- Submission Type