FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇪 Germany
MCINTOSH, MILLER, FOREGGER BABY
K Number: K945425
·
Decision Mar 20, 1995
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
30
Review Days
136
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Basic Information
- Device Name
- MCINTOSH, MILLER, FOREGGER BABY
- K Number
- K945425
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Rudolf Riester GmbH & Co. KG
- Date Received
- November 4, 1994
- Decision Date
- March 20, 1995
- Product Code
- CCW
- 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 |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | FDA class 1 | Anesthesiology |
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Other Clearances by Rudolf Riester GmbH & Co. KG
| K Number | Device Name | ||
|---|---|---|---|
| K002955 | EMPIRE N BLOOD PRESSURE MANOMETERS | Dec 21, 2000 | Substantially Equivalent |
| K002954 | RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS | Dec 21, 2000 | Substantially Equivalent |
| K972377 | RI-MEGA | Sep 24, 1997 | Substantially Equivalent |
| K972378 | SANAPHON N | Sep 24, 1997 | Substantially Equivalent |
| K972379 | PRECISA N | Sep 24, 1997 | Substantially Equivalent |
| K972301 | BIG BEN SQUARE, BIG BEN ROUND | Sep 17, 1997 | Substantially Equivalent |
| K964338 | RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT | Jan 9, 1997 | Substantially Equivalent |
| K950914 | RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V | Jul 24, 1995 | Substantially Equivalent |
| K950913 | PERFECT, ENT SET, PRAKTIKANT, DE LUXE | May 12, 1995 | Substantially Equivalent |
| K945541 | SCHIOTZ TONOMETER SPEC. 5 STRAIGHT, INCLINED, 3INCLINED SCALE | May 8, 1995 | Substantially Equivalent |