FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HLR QUICK-FIT HEART-LUNG RESUSCITATOR
K Number: K761194
·
Decision Dec 9, 1976
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
44
Applicant Total
5
Review Days
3
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Basic Information
- Device Name
- HLR QUICK-FIT HEART-LUNG RESUSCITATOR
- K Number
- K761194
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Mckesson Corp.
- Date Received
- December 6, 1976
- Decision Date
- December 9, 1976
- Product Code
- DRM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRM | Compressor, Cardiac, External | FDA class 2 | Cardiovascular |
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Other Clearances by Mckesson Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K771175 | RESUSCITATOR, MS30 | Aug 2, 1977 | Substantially Equivalent |
| K761196 | NITROUS OXIDE SCAVENGING MASK | Dec 13, 1976 | Substantially Equivalent |
| K761195 | ESOPHAGEAL OBTURATION AIRWAY | Dec 9, 1976 | Substantially Equivalent |
| K760017 | CONSIOUS SEDATION (ANALOR P-76) | Jul 20, 1976 | Substantially Equivalent |