FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KRYPTON CART
K Number: K811677
·
Decision Jul 2, 1981
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
24
Applicant Total
9
Review Days
17
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Basic Information
- Device Name
- KRYPTON CART
- K Number
- K811677
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Physics Inc. Dba Nycomed Amersham Imaging
- Date Received
- June 15, 1981
- Decision Date
- July 2, 1981
- Product Code
- KPY
- 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 |
|---|---|---|---|
| KPY | Shield, Protective, Personnel | FDA class 1 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KPY), ordered by most recent decision date.
DISPOSABLE THYROID COLLAR
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INTRA-ORAL THERMOPLASTIC SHIELD
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THERMOPLASTIC SHIELD
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UTK-DTE AUTILARY SHIELD
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AUKULYTE
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2001 SPECIAL PROCEDURE LAMP (LOW VOLTAGE) (AS EXHIBITS #2 & 4)
FDA 510(k)
FDA Class 1
·Radiology
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 |
| K811688 | TUNGSTEN SYRINGE SHIELD | Jul 2, 1981 | Substantially Equivalent |
| K811118 | KRYPTON MASKS & TUBING | Jun 2, 1981 | Substantially Equivalent |