PULMOTRACK,MODEL 1010
FDA 510(k) clearance K980878 · decided 1998-12-28
Clearance details
- K-number
- K980878
- Device name
- PULMOTRACK,MODEL 1010
- Applicant
- Karmel Medical Acoustic Technologies , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-09
- Decision date
- 1998-12-28
- Days to decision
- 294 days
- Clearance type
- Traditional
- Product code
- BZM
- Device class
- 2
- Regulation number
- 868.1900
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Tirat Hacarmel, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.