Stat-Sat
FDA 510(k) K874839 · Gish Biomedical, Inc.
510(k) numberK874839
Submission
- Device name
- Stat-Sat
- Applicant
- Gish Biomedical, Inc.
Santa Ana, CA, US - Received
- November 24, 1987
- Decision date
- May 13, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4330
- Specialty
- Cardiovascular
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|---|---|---|
| K090450 | Medos Hilite Pediatric Oxygenator, Models 2800, 2400 LTDTZ · Traditional | 09/18/2009SE |
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| K091062 | Medos Hilite Infant Reservoir, Model MVC 0730DTN · Traditional | 08/04/2009SE |
| K083131 | Medos Hilite Reservoir, Model: 4030DTN · Traditional | 07/30/2009SE |
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| K082082 | Gish SVR Soft Venous Reservoirs with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K081947 | Gish CAPVRF44 Hardshell Venous Reservoir with Ha CoatingDTN · Traditional | 02/04/2009SE |
| K080708 | Vision Hollow Fiber Oxygenator with Ha CoatingDTZ · Traditional | 02/02/2009SE |
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Questions and answers
When was Stat-Sat cleared by the FDA?
Stat-Sat (K874839) received a 510(k) decision of Substantially Equivalent on May 13, 1988, 171 days after the submission was received.
What is the product code of K874839?
The FDA product code is DRY – Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4330.