FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CORRUGATED TUBING #770 & 771
K Number: K770593
·
Decision Apr 19, 1977
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
87
Applicant Total
19
Review Days
22
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Basic Information
- Device Name
- CORRUGATED TUBING #770 & 771
- K Number
- K770593
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5975
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Surgicot, Inc.
- Date Received
- March 28, 1977
- Decision Date
- April 19, 1977
- Product Code
- BZO
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BZO | Set, Tubing And Support, Ventilator (W Harness) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZO), ordered by most recent decision date.
UNICOR, INC. CORRUGATED TUBING
FDA 510(k)
FDA Class 1
·Anesthesiology
UNICOR, INC. VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VENTILATOR HOSES
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA CUSTOM ANESTESIA CIRCUIT
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA BREATHING BAGS
FDA 510(k)
FDA Class 1
·Anesthesiology
PRIMA VOLUMN VENTILATORSS
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Surgicot, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962605 | PRO-GUARD DOUBLE-DUTY STERILIZATION WRAP (SINGLE USE) | Mar 11, 1997 | Substantially Equivalent |
| K931270 | SURGICLEAN ENZYMATIC INSTRUMENT CLEANER | Apr 13, 1994 | Substantially Equivalent |
| K863122 | ASSERT BIOLOGICAL/CHEMICAL INDICATOR 12 MONTH EXP. | Dec 17, 1986 | Substantially Equivalent |
| K855101 | ASSERT TM BIOLOGICAL/CHEMICAL INDICATOR | Jul 17, 1986 | Substantially Equivalent |
| K854631 | ASSERT EO BIOLOGICAL TEST PACK | May 27, 1986 | Substantially Equivalent |
| K854902 | SURGICOT STEAM TEST PACK | May 20, 1986 | Substantially Equivalent |
| K840541 | NEURO SPONGE | Apr 23, 1984 | Substantially Equivalent |
| K840471 | EYE SPEAR | Mar 16, 1984 | Substantially Equivalent |
| K840470 | SURGISCRIBE MARKING PEN | Mar 12, 1984 | Substantially Equivalent |
| K830739 | PRO-GUARD | Mar 29, 1983 | Substantially Equivalent |