3M Model 3000 & Model 3100 Infusion Pump (Modification)
FDA 510(k) K940446 · Minnesota Mining and Mfg. Co.
510(k) numberK940446
Submission
- Device name
- 3M Model 3000 & Model 3100 Infusion Pump (Modification)
- Applicant
- Minnesota Mining and Mfg. Co.
St. Paul, MN, US - Received
- February 1, 1994
- Decision date
- August 15, 1994
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
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Questions and answers
When was 3M Model 3000 & Model 3100 Infusion Pump (Modification) cleared by the FDA?
3M Model 3000 & Model 3100 Infusion Pump (Modification) (K940446) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on August 15, 1994, 195 days after the submission was received.
What is the product code of K940446?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.