Cook Test Tube Heater
FDA 510(k) K983609 · Cook Ob/Gyn
510(k) numberK983609
Submission
- Device name
- Cook Test Tube Heater
- Applicant
- Cook Ob/Gyn
Spencer, IN, US - Received
- October 14, 1998
- Decision date
- December 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQG – Accessory, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6120
- Specialty
- Obstetrics/Gynecology
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| K160753 | COOK Vacuum PumpMQG · Traditional | William A. Cook Australia Pty. , Ltd. | 06/13/2017SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K062438 | Bakri Postpartum Balloon, Model J-SOS-100500KNA · Traditional | 10/27/2006SE |
| K030441 | Sydney Ivf Blastocyst Cryopreservation Kit and Sydney Ivf Blastocyst Thaw KitMQL · Traditional | 08/29/2003SE |
| K023850 | Sydney Ivf Embryo Biopsy MediumMQL · Traditional | 01/22/2003SE |
| K013597 | Tamponade Uterine Balloon Catheter SetKNA · Traditional | 04/17/2002SE |
| K002385 | Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf Fertilization…MQL · Traditional | 09/18/2000SE |
| K002383 | Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient KitMQL · Traditional | 09/13/2000SE |
| K983595 | Transmyometrial Embryo Transfer SetMQF · Traditional | 02/08/1999SE |
| K983596 | Intracytoplasmic Sperm Injection (Icsi) Micro-Injection Pipettes, Holding Pipettes…MQH · Traditional | 02/05/1999SE |
| K983642 | Cook Mini-IncubatorMQG · Traditional | 02/01/1999SE |
| K983593 | Ovum Pick-Up Aspiration NeedlesMQE · Traditional | 01/21/1999SE |
Questions and answers
When was Cook Test Tube Heater cleared by the FDA?
Cook Test Tube Heater (K983609) received a 510(k) decision of Substantially Equivalent on December 16, 1998, 63 days after the submission was received.
What is the product code of K983609?
The FDA product code is MQG – Accessory, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6120.