Gold Gators
FDA 510(k) K903729 · Lead-Lok, Inc.
510(k) numberK903729
Submission
- Device name
- Gold Gators
- Applicant
- Lead-Lok, Inc.
Sandpoint, ID, US - Received
- August 16, 1990
- Decision date
- September 14, 1990
- 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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More from Terumo Cardiovascular Systems Corp.
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| K911529 | Bunny Electrode/Stealth Electrode Pre Wired EEGDRX · Traditional | 11/09/1992SE |
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Questions and answers
When was Gold Gators cleared by the FDA?
Gold Gators (K903729) received a 510(k) decision of Substantially Equivalent on September 14, 1990, 29 days after the submission was received.
What is the product code of K903729?
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.