SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
FDA 510(k) clearance K012229 · decided 2001-09-10
Clearance details
- K-number
- K012229
- Device name
- SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C & 20009, MODEL N661WC
- Applicant
- National Custom Ent., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-16
- Decision date
- 2001-09-10
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- FMT
- Device class
- 2
- Regulation number
- 880.5130
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Burnsville, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.