Data / Medical devices / United States / Pcci, Inc
Pcci, Inc: FDA-registered device maker in Alexandria, VA, United States, 6 510(k) clearances
Pcci, Inc is registered with the FDA (registration 3004035771) in Alexandria, VA, United States. It lists 1 device type. The FDA files 6 510(k) clearances under its listings, the newest dated August 19, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004035771
- Address
- 300 N Lee ST Ste 201, Alexandria, VA, United States, 22314
- Owner or operator
- PCCI, INC (9104700)
- Roles
- Manufacturer
- First device listed
- November 9, 2016
- Registered through
- 2026
- Brand names listed
- Althea 4200, DL-5-USG, Ods1 - Hood Driver, PCCI GSP1, PCCI Lifeforce Clinical Hyperbaric Facility, T Class Hyperbaric Facilities
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Chamber, Hyperbaric | CBF | 2 | 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 |
|---|---|---|---|---|---|---|
| August 19, 2011 | K102831 | RSI 4200 | CBF | Substantially Equivalent | Reimers Systems, Inc. | accessdata.fda.gov |
| October 23, 1996 | K962871 | ODS1 - HOOD DRIVER | CBF | Substantially Equivalent | Reimers Systems, Inc. | accessdata.fda.gov |
| October 23, 1996 | K962869 | GSP1 - GAS SELECTION PANEL | CBF | Substantially Equivalent | Reimers Systems, Inc. | accessdata.fda.gov |
| December 15, 1995 | K954387 | T CLASS HYPERBARIC FACILITIES | CBF | Substantially Equivalent | Reimers Systems, Inc. | accessdata.fda.gov |
| June 2, 1995 | K951125 | LIFEFORCE CLINICAL HYPERBARIC FACILITY | CBF | Substantially Equivalent | Reimers Systems, Inc. | accessdata.fda.gov |
| July 22, 1991 | K905168 | HYPERLITE | CBF | Substantially Equivalent | S.O.S. , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 19, 2011. 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.