FLUID MANAGEMENT SYSTEM— 510(k) K972284
Substantially Equivalent - Subject to Tracking Reg.Belmont Instrument Corp.
FDA 510(k) clearance K972284 for FLUID MANAGEMENT SYSTEM, Substantially Equivalent - Subject to Tracking Reg. on 1997-11-13. Applicant: Belmont Instrument Corp.. Device class: 2.
Clearance details
- Applicant
- Belmont Instrument Corp.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Clearance type
- Traditional
- Location
- Billerica, MA, US
Recent devices under product code FRN
view all- K253703 — RemunityPRO+ Pump for Remodulin® (treprostinil) Injection
- K252015 — FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate Tubing
- K251636 — Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)
- K251640 — SIGMA Spectrum Infusion Pump with Master Drug Library
- K242752 — MRidium 3870 MRI Infusion Pump System (3870)
More clearances from Belmont Instrument Corp.
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K972284
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972284.
Data sourced from openFDA. This site is unofficial and independent of the FDA.