Data / Medical devices / United States / Sea-Long Medical Systems, LLC
Sea-Long Medical Systems, LLC: FDA-registered device maker in Waxahachie, TX, United States, 1 510(k) clearance
Sea-Long Medical Systems, LLC is registered with the FDA (registration 3013976593) in Waxahachie, TX, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 16, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013976593
- FEI number
- 1037230
- Address
- 2498 FM66 Building 1021, Waxahachie, TX, United States, 75167
- Owner or operator
- Sea-long Medical Systems, LLC (10056562)
- Roles
- Manufacturer
- First device listed
- December 21, 2017
- Registered through
- 2026
- Brand names listed
- HBOT Oxygen Hood, PN5000 Series, Sea-Long Medical Helmet
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Hyperbaric | CBF | 2 | Manufacturer | accessdata.fda.gov |
| Hood, Oxygen, Infant | FOG | 1 | Manufacturer | accessdata.fda.gov |
| Tent, Oxygen | BYL | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 16, 2001 | K010659 | SEA-LONG MEDICAL TREATMENT HOOD | CBF | Substantially Equivalent | Sea-Long Medical Systems, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 16, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.