FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDO-JECT
K Number: K840943
·
Decision May 25, 1984
Classifications
1
FEI Numbers
132
Registration Numbers
132
Same Product Code
240
Applicant Total
7
Review Days
81
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Basic Information
- Device Name
- ENDO-JECT
- K Number
- K840943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5730
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Autovage
- Date Received
- March 5, 1984
- Decision Date
- May 25, 1984
- Product Code
- BTR
- 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 |
|---|---|---|---|
| BTR | Tube, Tracheal (W/Wo Connector) | FDA class 2 | Anesthesiology |
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Other Clearances by Autovage
| K Number | Device Name | ||
|---|---|---|---|
| K922785 | IRRIVAGE | Oct 16, 1992 | Substantially Equivalent |
| K914908 | QUICVAGE PLUS | Apr 13, 1992 | Unknown |
| K914907 | QUICVAGE | Jan 24, 1992 | Substantially Equivalent |
| K911788 | ECONOVAGE R | Jul 26, 1991 | Substantially Equivalent |
| K911919 | MINIVAGE(R) | Jul 26, 1991 | Substantially Equivalent |
| K823195 | GASTRIC LAVAGE KIT | Dec 3, 1982 | Substantially Equivalent |