510(k) K834129
K834129 is an FDA 510(k) premarket notification submitted by Medela, Inc. for the device "MEDELA APGAR TIMER". The FDA issued a decision of Substantially Equivalent on January 10, 1984. The device falls under product code LHB (Timer, Apgar), a Class I device regulated under 21 CFR 880.2930. Medela, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 10, 1984
- Date Received
- November 30, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Timer, Apgar
- Device Class
- Class I
- Regulation Number
- 880.2930
- Review Panel
- HO
- Submission Type