FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
TUBE-STRAP
K Number: K791781
·
Decision Sep 19, 1979
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
18
Applicant Total
37
Review Days
8
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Basic Information
- Device Name
- TUBE-STRAP
- K Number
- K791781
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5280
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Olympic Medical Corp.
- Date Received
- September 11, 1979
- Decision Date
- September 19, 1979
- Product Code
- JAY
- 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 |
|---|---|---|---|
| JAY | Support, Breathing Tube | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAY), ordered by most recent decision date.
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ENDO-SECURE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Olympic Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K081094 | OLYMPIC PASTEURMATIC, MODELS 3000 AND 3500 | Jun 20, 2008 | Substantially Equivalent |
| K031149 | OLYMPIC CFM 6000 | May 14, 2003 | Substantially Equivalent |
| K020335 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330 | Jun 18, 2002 | Substantially Equivalent |
| K001056 | OLYMPIC WARM-UP | Sep 29, 2000 | Substantially Equivalent |
| K983229 | OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM | Mar 23, 1999 | Substantially Equivalent |
| K971601 | OLYMPIC BILI-BASSINET | Sep 24, 1997 | Substantially Equivalent |
| K972193 | OLYMPIX MINI-PASTEURMATIC (58210) | Sep 5, 1997 | Substantially Equivalent |
| K971117 | WARMETTE | Aug 22, 1997 | Substantially Equivalent |
| K955357 | OLYMPIC SMART SCALE MODEL 50/50RA | Jan 30, 1996 | Substantially Equivalent |
| K954434 | OLYMPIC INFANT THERMOMETER | Dec 20, 1995 | Substantially Equivalent |