FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KRYPTON MASKS & TUBING
K Number: K811118
·
Decision Jun 2, 1981
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
47
Applicant Total
9
Review Days
39
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Basic Information
- Device Name
- KRYPTON MASKS & TUBING
- K Number
- K811118
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1390
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Physics Inc. Dba Nycomed Amersham Imaging
- Date Received
- April 24, 1981
- Decision Date
- June 2, 1981
- Product Code
- IYT
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| IYT | System, Rebreathing, Radionuclide | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IYT), ordered by most recent decision date.
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BOLUS XENON CIRCUIT
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Other Clearances by Medi-Physics Inc. Dba Nycomed Amersham Imaging
| K Number | Device Name | ||
|---|---|---|---|
| K010821 | ECHOSEED/IODINE-125 SEEDS, MODEL 6733 | Apr 11, 2001 | Substantially Equivalent |
| K940632 | I-125 RAPID STRAND | Sep 2, 1994 | Substantially Equivalent |
| K921961 | SDMO APPLICATOR CODE: ASN.8236 | Jul 1, 1992 | Substantially Equivalent |
| K915156 | I-125 SEEDS CODE: 6702 | Jan 6, 1992 | Substantially Equivalent |
| K914268 | I-125 SEEDS IN CARRIER, CODE: 6720 | Nov 22, 1991 | Substantially Equivalent |
| K914281 | I-125 SEEDS, CODE: 6711 | Nov 22, 1991 | Substantially Equivalent |
| K811677 | KRYPTON CART | Jul 2, 1981 | Substantially Equivalent |
| K811688 | TUNGSTEN SYRINGE SHIELD | Jul 2, 1981 | Substantially Equivalent |