510(k) K040044
K040044 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "HEEL SNUGGLER, MODEL 99047". The FDA issued a decision of Substantially Equivalent on January 27, 2004. The device falls under product code MPO (Infant Heel Warmer (Chemical Heat Pack)), a Class I device regulated under 21 CFR 890.5710. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2004
- Date Received
- January 12, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Infant Heel Warmer (Chemical Heat Pack)
- Device Class
- Class I
- Regulation Number
- 890.5710
- Review Panel
- PM
- Submission Type