510(k) K884436
K884436 is an FDA 510(k) premarket notification submitted by Harris Mfg. Co. for the device "MODIFIED LOW-TEMP. FREEZER MODEL HLT-80LS-85". The FDA issued a decision of Substantially Equivalent on December 2, 1988. The device falls under product code KSE (Refrigerator, Freezer, Blood Storage), a Class II device regulated under 21 CFR 864.9700. Harris Mfg. Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 2, 1988
- Date Received
- October 21, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Refrigerator, Freezer, Blood Storage
- Device Class
- Class II
- Regulation Number
- 864.9700
- Review Panel
- HE
- Submission Type