Pump Infusion Wearable Infusion Pump
FDA 510(k) K833966 · Oximetrix, Inc.
510(k) numberK833966
Submission
- Device name
- Pump Infusion Wearable Infusion Pump
- Applicant
- Oximetrix, Inc.
Walker, MI, US - Received
- November 16, 1983
- Decision date
- January 25, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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| K881578 | StreptoselJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
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| K881570 | Sabouraud Maltose AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881565 | Inhibitory Mold AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881547 | Mitis Salivarius AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K853018 | Model 3000 Opticath ComputerDXG · Traditional | 01/13/1986SE |
| K842622 | Hemo Static/Esu Scalpel SystemGEI · Traditional | 10/23/1984SE |
| K823007 | Opticath Heparin Coated, Flow-DirectDYG · Traditional | 11/01/1982SE |
| K821057 | Flow Directed Thermal-Dilution InfusionDYG · Traditional | 05/18/1982SE |
| K821056 | Flow Directed Thermal-Dilution Catheter · Traditional | 05/18/1982SE |
| K820674 | OpticathDQE · Traditional | 03/25/1982SE |
| K811391 | Oximetrix Accu Sat CPBDRY · Traditional | 07/20/1981SE |
| K791868 | Oximetrix Shaw Hemostatic Surg. Sys.GEI · Traditional | 01/04/1980SE |
| K781879 | Heater, Oximeter SystemDQA · Traditional | 01/08/1979SE |
| K781134 | Catheter, Thermal Dilution FiberopticDQE · Traditional | 08/17/1978SE |
Questions and answers
When was Pump Infusion Wearable Infusion Pump cleared by the FDA?
Pump Infusion Wearable Infusion Pump (K833966) received a 510(k) decision of Substantially Equivalent on January 25, 1984, 70 days after the submission was received.
What is the product code of K833966?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.