FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGI-INJECTOR
K Number: K971067
·
Decision Sep 19, 1997
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
18
Applicant Total
22
Review Days
179
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Basic Information
- Device Name
- DIGI-INJECTOR
- K Number
- K971067
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Instrument Development Laboratories, Inc.
- Date Received
- March 24, 1997
- Decision Date
- September 19, 1997
- Product Code
- MRH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | FDA class 2 | General Hospital |
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Other Clearances by Medical Instrument Development Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K102222 | ULTIMATE VIT ENHAMCER (UVE) | Apr 8, 2011 | Substantially Equivalent |
| K020911 | MID LABS AUTONOMOUS VIT ENHANCER (AVE) | Apr 29, 2002 | Substantially Equivalent |
| K992943 | VIT ENHANCER | Dec 10, 1999 | Substantially Equivalent |
| K950287 | UNIVIT PROBE | Apr 10, 1995 | Substantially Equivalent |
| K934600 | MICRODRIVE | Jul 27, 1994 | Substantially Equivalent |
| K932669 | SUPRA-VIT(TM) | Jun 3, 1994 | Substantially Equivalent |
| K932131 | MID LABS TWIN ILLUMINATOR | Apr 1, 1994 | Substantially Equivalent |
| K924222 | MID LABS, INC. VIT MATE | Jan 27, 1993 | Substantially Equivalent |
| K851610 | COMBINED MVS SYSTEMS | Jul 22, 1985 | Substantially Equivalent |
| K851009 | INFUSION SLEEVE - OPHTHALMIC | Apr 3, 1985 | Substantially Equivalent |