LINDE MARK II
FDA 510(k) clearance K812536 · decided 1981-09-23
Clearance details
- K-number
- K812536
- Device name
- LINDE MARK II
- Applicant
- Union Carbide Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-09-03
- Decision date
- 1981-09-23
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- BYJ
- Device class
- 2
- Regulation number
- 868.5655
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| MODIFICATION TO: SPIRIT (K080023) | Caire, Inc. | 2008-06-16 |
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| COPD LIQUID OXYGEN PORTABLE, MODEL 300P (K072011) | Copd Partners, Inc. | 2007-10-18 |
| BACKPACK MEDICAL OXYGEN SYSTEM (K071581) | Essex Cryogenics of Missouri, Inc. | 2007-07-11 |
| SPIRIT, MODEL HAS (K050153) | Caire, Inc. | 2005-04-15 |
| PLIX (K050414) | Respironics, Inc. | 2005-04-11 |
| PRECISION LIQUID OXYGEN SYSTEM (K041122) | Precision Medical, Inc. | 2004-10-04 |
Recalls involving this device
No recalls on record reference this clearance.