FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL INJECTOR SYS
K Number: K833138
·
Decision Nov 14, 1983
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
37
Review Days
61
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Basic Information
- Device Name
- DIGITAL INJECTOR SYS
- K Number
- K833138
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Sybron Corp.
- Date Received
- September 14, 1983
- Decision Date
- November 14, 1983
- Product Code
- DXT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
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Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr
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Other Clearances by Sybron Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K862284 | SEALITE | Jun 23, 1986 | Substantially Equivalent |
| K854855 | PROOF ALGINATE IMPRESSION MATERIAL | Jan 30, 1986 | Substantially Equivalent |
| K844092 | DIAGNOSTIC MICROSOPCE SLIDES | Oct 25, 1984 | Substantially Equivalent |
| K842132 | TYCOS SELF-CHECK/DIGITAL FEVER THERMO | Jul 18, 1984 | Substantially Equivalent |
| K841910 | KERR SEALAPEX ROOT CANAL SEALER | Jul 13, 1984 | Substantially Equivalent |
| K841732 | LIEBEL-FLARSHEIM AFC 1000 X-RAY FILM | Jun 5, 1984 | Substantially Equivalent |
| K840469 | TYCOS SELF CHECK BPM3 BLOOD PRESS MONI | May 21, 1984 | Substantially Equivalent |
| K840407 | KERR RESIN BONDED BRIDGE CEMENT | May 21, 1984 | Substantially Equivalent |
| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | Mar 5, 1984 | Substantially Equivalent |
| K823795 | EVERBOND GLASS IONOMER CEMENT | Jan 26, 1983 | Substantially Equivalent |