510(k) K881885
K881885 is an FDA 510(k) premarket notification submitted by Dowit Service Co., Inc. for the device "BATTERY PACKS (OTHER THAN CV)". The FDA issued a decision of Substantially Equivalent on July 26, 1988. The device falls under product code FCP (Box, Battery, Pocket), a Class I device regulated under 21 CFR 876.1500. Dowit Service Co., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1988
- Date Received
- May 4, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Box, Battery, Pocket
- Device Class
- Class I
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type